EP0629101B1 - Hearing aid to be worn in the ear and method for manufacturing the same - Google Patents

Hearing aid to be worn in the ear and method for manufacturing the same Download PDF

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Publication number
EP0629101B1
EP0629101B1 EP94810287A EP94810287A EP0629101B1 EP 0629101 B1 EP0629101 B1 EP 0629101B1 EP 94810287 A EP94810287 A EP 94810287A EP 94810287 A EP94810287 A EP 94810287A EP 0629101 B1 EP0629101 B1 EP 0629101B1
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EP
European Patent Office
Prior art keywords
hearing aid
skeleton
aid according
auditory canal
diaphragm
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP94810287A
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German (de)
French (fr)
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EP0629101A1 (en
Inventor
Walter Aebi
Elmar Mock
Grégoire Iten
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bernafon AG
Original Assignee
Ascom Audiosys AG
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Publication date
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Publication of EP0629101A1 publication Critical patent/EP0629101A1/en
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Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/652—Ear tips; Ear moulds
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/658—Manufacture of housing parts
    • H04R25/659—Post-processing of hybrid ear moulds for customisation, e.g. in-situ curing

Definitions

  • the invention relates to a hearing aid to be worn in the ear and to a method for their manufacture according to the generic terms of the corresponding independent Claims.
  • the most common method of making in the ear too Wearing hearing aids consist of a hearing aid consultant who at the same time examines the hearing impairments of the potential user Silicone cast of the ear canal that is made after this silicone cast a transparent, positive model of the ear canal is created and that in this model a plastic polymerizing with the help of light is poured from the outside to the inside up to a certain layer thickness hardens.
  • a hollow molded body is created, in which the electronic components of the hearing aid are installed, wherein at least one opening for the loudspeaker and for the inside of the ear a pressure equalization channel can be arranged.
  • the ear canal is closed with a lid that in turn an opening for the pressure equalization channel and a separate compartment for a replaceable battery.
  • the hearing aid produced in this way has a molded body with a very good one Fit, but the skin of the ear canal is so complete covers that there can be no question of ventilation. This also leads inevitably leads to increased excretion of sweat and cerumen.
  • the between The eardrum and hearing aid remain part of the ear canal through the pressure equalization channel open to the outside, so that pressure equalization take place and moisture can escape.
  • the pressure equalization channel But can in turn the feedback between speakers and raise the microphone.
  • the method described for producing the hearing aid is complex, because the molded body is cast in several positive-negative steps must and because these manufacturing steps are such that they are not provided by the hearing aid consultant can be run yourself. In other words, the manufacturer of the hearing aids has to deal with the individual completion of individual, user-specific devices.
  • U.S. Patent No. 4962537 proposes the molded body in the form of a double-walled sack from one to provide flexible material, directly in the user's ear between a hardening plastic mass is pressed on the two walls.
  • This method can save some manufacturing process steps but the cast molded body still has to be reworked , in particular an opening for a pressure compensation channel must be made on it and retrofitted for the speaker, and it is doubtful whether this will be done by the hearing aid advisor himself can.
  • Publication US-5131411 describes a hearing aid who also created one in an individual ear canal Has molded body. This is made by foaming of a foamable material that is not yet individualized Hearing aid is provided in an unfoamed state and that immediately before the not yet individualized hearing aid positioned in an individual ear canal to Foaming is brought. To improve the surface of the finished hearing aid can be between the ear canal wall and foamed Shaped body a fine membrane can be provided.
  • the publication FR-2667500 describes the manufacture of an ear plug described.
  • the earplug is made by a pouring stocking attached to a cover plate into which a Giesskanal leads, positioned in an individual ear canal and by pouring the casting stocking through the pouring channel with a hardening casting compound is filled.
  • the one surrounded by the stocking Shaped body takes the shape of the individual ear canal on.
  • the earplug can be used as hearing protection or provided with a hearing aid unit after casting and to be made into a hearing aid.
  • the object of the invention to have a hearing aid to be worn in the ear to create a molded body adapted to an individual ear canal, the hearing aid on the one hand in relation to comfort compared to known such hearing aids has improvements and on the other hand in a simpler process can be produced, in particular individualized can. Furthermore, a method must be specified by which the hearing aid is manufactured, especially individualized.
  • the method according to the invention is roughly outlined as follows: a general standard (not yet on an individual ear canal adapted) hearing aid.
  • This advantageously has a limited plastically deformable skeleton on which the electronic components of the Hearing aid and to which a flexible membrane is attached such that a skeleton and membrane form a casting space that faces the outside has an open pouring channel.
  • the hearing aid is now individualized (on customized an individual ear canal) by matching the skeleton the individual shape of the ear canal is deformed by already being so partially customized hearing aid positioned in the ear and then the casting room is poured out with a hardening plastic mass, the The membrane is deformed and the resulting molded body changes accordingly Ear canal shapes.
  • the skeleton and membrane are designed and attached to each other that no reworking due to skeletal deformation and Pouring the molded body of individualized hearing aid is necessary.
  • the material and the structure of the membrane are such that they pass through an extremely fine porosity and corresponding surface quality for gases permeable, but impermeable to liquids and that they are sufficient is elastic in order to be as wrinkle-free as possible when casting the molded body to be able to put on the ear canal wall.
  • the membrane is not just that perpendicular to their surfaces permeable to gas but also parallel to it, such that not only through this membrane the air displaced during casting can escape, but that they are also used as a pressure compensation and Ventilation of the ear canal skin can serve. This property can still be increased by the membrane on its side facing the skeleton a coarse porous intermediate layer that carries a layer of an open pore Foam or a network can be. So that the membrane functions can also exercise for a long time, it is also water and oil repellent.
  • a foamed and stretched PTFE membrane is under the name GORE-TEX® by W.L. Gore & Co GmbH (D-88011 Putzbrunn near Munich) is produced, which has the required properties and is suitable for use. It is a foamed one and stretched PTFE material (polytetrafluoroethane), the one finely porous membrane.
  • This membrane has not only the ones in demand physical properties, but is very skin and body friendly (It can also be used as a temporary skin for large wounds become).
  • membrane materials are woven from plastic fibers, for example, knitted or knitted materials conceivable that at least on the the surface facing the ear canal are coated with an oil and water repellent layer.
  • This layer can, for example, be vapor-deposited Layer of Parylen® (Union Carbide Corp., USA) or silane.
  • Figure 1 shows the principle of the hearing aid according to the invention in a very schematic manner.
  • the hearing aid is shown cut in its already individualized state and parallel to the axis of the auditory canal. It essentially has the shape of an irregular truncated cone with a lateral surface M, a larger end face AS directed towards the outside in the auditory canal and a smaller end face IS facing towards the inside in the auditory canal.
  • the hearing aid consists essentially of a molded body 1, which in its Shape is adapted to the ear canal and at least on the lateral surface M, that means where he touches the ear canal wall while wearing the device, is covered with a membrane 2 as already described.
  • the hearing aid also has a skeleton consisting essentially of three parts: of an outer support element 3, which essentially the outer end face AS the device forms an inner support member 4, which is essentially the forms the inner end face of the device, and a connecting element 5, the connects the two support elements 3 and 4 together.
  • the connecting element 5 serves to support the two support elements 3 and 4 before casting the To keep the shaped body in a mutual position, the roughly an ear canal corresponds.
  • the connecting element 5 is advantageously limited deformable, so that the first individualization step is the mutual Position of the support elements 3 and 4 adapted to the individual ear canal can be.
  • the outer support element 3 carries a microphone 31, for which it is connected to the corresponding Place is provided with sound passage openings 32. Furthermore forms the outer support element 3 has a lockable battery compartment 33 and carries one Pouring or injection opening 34.
  • the inner support element 4 carries a loudspeaker 41 and is also included Sound passage openings 42 provided.
  • the membrane 2 which the molded body at least on its lateral surface M surrounds, is around the two end faces AS and IS on the two support elements attached (digits X in the figure).
  • the membrane 2 can additionally completely span the inner end face IS. You can also use the outer face partially spanning, but must the pouring or injection opening 34 and leave the battery compartment 33 freely accessible.
  • the amplifier electronics can either be from one of the Carrying elements or worn by the connecting element. It can too be cast into the molded body without special attachment to the skeleton.
  • the skeleton is advantageously made of plastic.
  • the membrane can the supporting elements, for example by welding, by gluing or be fastened by appropriate tensioning elements. Other mounting options are described in connection with Figures 2 to 4.
  • the general hearing aid from which the one shown schematically in FIG. individualized hearing aid, differs from this in that that the molded body 1 only as an undetermined casting cavity between Support elements and membrane is present.
  • the on the support elements 3 and 4 attached membrane 2 surrounds the skeleton loosely and forms the supporting elements together form a substantially tubular skeleton surrounding casting room, which opens through the pouring channel 34 to the outside.
  • the casting space between the membrane and the skeleton is through the pouring channel 34 Poured out with a suitable plastic while the hearing aid is in the ear canal is positioned.
  • the plastic hardens to an individualized molded body 1.
  • the requirements for the plastic are that it is easy to get through the pouring channel can be poured in and that it hardens quickly. Of course, it must be skin-friendly.
  • casting compounds can also be used.
  • Advantageously such materials are used in the polymerization do not split off any low molecular weight residues.
  • the casting compound can Improvement of the properties of the molded body as a sound and vibration damper Additives, for example small foam bodies or hollow glass balls, be added.
  • the steps necessary to individualize the general hearing aid are deforming the skeleton and casting the molded body. Both steps can be performed by the hearing aid consultant without any problems, such as that the user can take the hearing aid with them after a session and that the manufacturer only has to produce general hearing aids.
  • FIGS. 2 to 4 The exemplary embodiments shown in FIGS. 2 to 4
  • the hearing aid according to the invention essentially differ from one another in that the electronic components to different degrees are accessible.
  • the principle described in connection with Figure 1 is preserved in all embodiments.
  • FIG. 2 shows a first exemplary embodiment of the hearing aid according to the invention, again in section parallel to the auditory canal axis.
  • the device is positioned in an auditory canal, the auditory canal walls being indicated by the lines G.
  • the hearing aid shown is already individualized. It has a skeleton, which in turn consists of an outer support element 3, an inner support element 4 and a connecting element 5 and which carries the electronic components.
  • This skeleton is arranged in a cast molded body 1, the surface of which facing the auditory canal is covered by a sack-shaped membrane 2.
  • the two support elements 3 and 4 are designed as an inner capsule 4.1 with a inner closing element 4.2 and an outer capsule 3.1 with an outer Locking element 3.2 formed, through the at least partial accessibility of the electronic components on the individualized hearing aid becomes possible.
  • the speaker 41 is housed by the opening of which is introduced before the closing element 4.2 is placed on it becomes.
  • the outer capsule 3.1 are advantageously arranged accordingly Fan the microphone 31 in a microphone compartment 31.1 and in a battery compartment 33 accommodates a battery.
  • the amplifier electronics too 6 can be accommodated in the outer capsule 3.1.
  • the electrical Connections between the electronic components of the hearing aid run for example by the deformable connecting element 5.
  • pouring opening 34 is also arranged, for example on the outer capsule 3.1 molded.
  • the openings of the individual compartments of the outer capsule 3.1 and the opening of the pouring channel 34 advantageously lies essentially in one level, so that they are closed together by the locking element 3.2 can. It can also be separate for the different openings Closing elements may be provided or partial areas for individual openings of the common locking element 3.2 can be designed such that they can be opened and closed without the whole locking element 3.2 must be opened.
  • the battery compartment 33 is shown in FIG completed such a partial closing element 33.1 and thereby for the Easily accessible to users.
  • the sack-shaped membrane 2 has a main opening, the edge of which is all around the area in which the opening of the outer capsule 3.1 and the opening of the Giesskanals 34 are arranged such that the entire skeleton in the except for the opening of the pouring channel 34 and the opening of the outer capsule 3.1 is enclosed by the membrane 2.
  • the attachment the membrane 2 around the outer capsule is taken over by a outer membrane fixative, for example, from a form-fitting order the outer capsule arranged fixing ring 10 (on the left side of the figure shown) or by appropriately form-fitting design of the edge areas of the closing element 3.2 (shown on the right side of the figure) can exist. If the membrane 2 through the closing element 3.2 attached to the outer capsule 3.1, it is necessary that the closing element 3.2, as shown in the figure for the battery compartment 33, also for the Pour channel 34 a removable portion or at least one opening having.
  • the inner membrane fixing agent is, for example, the form-fitting perforated inner fitting to the opening of the inner capsule 4.1
  • Closing element 4.2 the membrane 2 around the opening of the capsule 4.1 holds in such a way that the casting compound cannot enter the opening, which the the capsule opening spanning part 21 of the membrane 2 in use protects mechanically and that is not an obstacle to the sound of the speaker represents (sound passage openings).
  • That part of the opening of the outer capsule 3.1 that is above the microphone compartment 31.1 is covered with a membrane.
  • a membrane This can, as shown in Figure 1, with a between closing element 4.2 and Capsule wall clamped, separate piece 22 of the membrane can be realized or in such a way that the membrane 2 also integrally over it Opening spans, being held in the same way as on the Opening the inner capsule 4.1.
  • the closing element 3.2 is advantageously perforated.
  • the membrane 2 can on the capsules or the corresponding closing elements As already mentioned, it can also be welded or glued on.
  • FIGS. 1 and 2 show a further embodiment of the hearing aid according to the invention.
  • the principle in turn corresponds to that described in connection with FIG. 1 and the basic components of the hearing aid are the same, so that both no longer need to be described.
  • the difference from the hearing aids according to FIGS. 1 and 2 is that the connecting element 5 is hollow and serves as a pressure compensation channel, for which purpose corresponding mouth openings 45 and 35 are provided in the inner (4) and in the outer supporting element 3.
  • the pouring opening 34 is arranged such that it opens into the battery compartment 33.
  • the inner end face IS is covered with a separate membrane piece 46, the area of the microphone 31 and the outer mouth opening 45 of the pressure compensation channel with a separate membrane piece 36.
  • Microphone 31 and loudspeaker 41 are cast directly by the casting compound or can be surrounded on the molded body side with a sound insulation material 37.
  • FIG. 3 shows the hearing aid in the general state as it is delivered by the manufacturer.
  • Figure 4 shows the hearing aid in the ear canal G, ready for pouring.
  • the battery and the battery compartment cover are removed.
  • the separate membrane pieces 36 and 46 (FIG. 3) are removed, and a protective element 48 is attached to the inner end face IS of the hearing aid through the pressure equalization channel with a wire 7, through which not only the eardrum should be protected during casting, but should also help to position the not yet individualized hearing aid in the ear canal.
  • the protective element 48 consists for example of foam.
  • the wire 7 carrying the protective element can additionally serve as an aid for inserting the hearing aid into the auditory canal and for removing it.
  • the membrane Before pouring, that is to say in the general state of the hearing aid, the membrane must already have a shape corresponding to a certain extent to the auditory canal, so that in the individualized state of the hearing aid it spans the molded body without wrinkles. In particular, it should be possible to attach it around its main opening (outer end face) and around the opening on the inner end face as wrinkle-free as possible. To do this, the membrane must be in the form of a sack that tapers away from the main opening. Such a membrane bag can, as shown in FIGS . 5a to 5c , be produced in different ways.
  • a bag S can be drawn from a flat piece ME of a membrane.
  • This method of manufacture requires sufficient deformability of the membrane, but is particularly advantageous if the membrane is to span the inner end face of the hearing aid, that is to say if the membrane bag is to have only one main opening but no further opening.
  • FIG. 5b shows a method for producing a membrane bag S, likewise from a flat membrane piece ME, from which a piece K is cut in the form of a unwound truncated cone. This piece K is welded to the membrane bag S with a main opening H and a further opening W.
  • FIG. 5c shows the production of a membrane bag again with a main opening H and a further opening W from a piece of membrane hose MS by expanding its one end to a larger diameter.
  • this on a second layer (intermediate layer) be brought up on the finished hearing aid between the Membrane and the molded body is arranged, so not with the skin of the Ear canal comes into contact.
  • this layer can be an open-cell foam or a mesh on which the membrane is drawn is. It turns out that such an intermediate layer is also used in production of the membrane bag.

Abstract

The hearing aid according to the invention consists of a skeleton which consists of an outer support element (3), an inner support element (4) and a connecting element (5) on which at least some of the electronic components (41, 42) of the hearing aid are arranged. The two support elements essentially form the end faces (IS, AS) of an irregular truncated cone. On the support elements, a diaphragm (2) is mounted in such a manner that it essentially forms the outer surface of the truncated cone. The diaphragm (2) and the skeleton (3/4/5) together form an essentially tubular moulding space in which a moulded body (1) matched to the individual auditory canal is cast in the ear of the user by means of a hardening casting compound. Before the casting process, the skeleton can be roughly matched to the individual auditory canal by appropriate deformation of the connecting element (5). The diaphragm (2) is permeable to gas but impermeable to liquid not only perpendicularly to its main surface but also parallel thereto, and it repels water and oil. <IMAGE>

Description

Die Erfindung betrifft eine im Ohr zu tragende Hörhilfe und ein Verfahren zu deren Herstellung gemäss den Oberbegriffen der entsprechenden unabhängigen Patentansprüche.The invention relates to a hearing aid to be worn in the ear and to a method for their manufacture according to the generic terms of the corresponding independent Claims.

Im Ohr zu tragende Hörhilfen weisen üblicherweise ein im Ohr gegen aussen angeordnetes Mikrophon, einen gegen das Ohrinnere weisenden Lautsprecher, eine verstärkende Elektronik und eine auswechselbare Batterie für den Betrieb auf, wobei alle diese elektronischen Bestandteile in einem Formkörper angeordnet sind, der in seiner Form mehr oder weniger der Form des Gehörganges angepasst ist und im Gehörgang getragen wird. Damit die Hörhilfe bequem getragen werden kann und damit sie ihre Funktion optimal ausüben kann, sind an den Formkörper verschiedene Anforderungen gestellt, die er je nach Ausführungsform mehr oder weniger gut erfüllt. Diese Anforderungen sind im wesentlichen die folgenden:

  • Der Formkörper soll möglichst gut in den Gehörgang passen, damit er gut sitzt und trotzdem bequem ist.
  • Der Formkörper soll leicht in den Gehörgang einführbar und aus dem Gehörgang entfernbar sein.
  • Der Formkörper soll trotz guter Passform einen Druckausgleich im Gehörgang ermöglichen.
  • Der Formkörper soll eine Rückkoppelung des durch den Lautsprecher erzeugten Schalls zum Mikrophon möglichst verhindern.
  • Der Formkörper soll gut hautverträglich sein, er soll insbesondere eine Belüftung der Haut des Gehörganges ermöglichen und Schweiss- und Cerumenausscheidung nicht anregen.
  • Der Formkörper soll unempfindlich sein gegen die Ausscheidungen des Gehörganges und einfach von diesen zu reinigen sein, insbesondere soll er auch die elektronischen Bestandteile der Hörhilfe vor diesen Ausscheidungen schützen.
Hearing aids to be worn in the ear usually have a microphone arranged in the ear towards the outside, a loudspeaker pointing towards the inside of the ear, amplifying electronics and a replaceable battery for operation, all of these electronic components being arranged in a shaped body which is more in shape or less adapted to the shape of the ear canal and worn in the ear canal. So that the hearing aid can be worn comfortably and so that it can perform its function optimally, various requirements are placed on the molded body, which it more or less fulfills depending on the embodiment. These requirements are essentially the following:
  • The molded body should fit into the ear canal as well as possible so that it sits well and is still comfortable.
  • The molded body should be easy to insert into the auditory canal and removable from the auditory canal.
  • The molded body should enable pressure equalization in the ear canal despite a good fit.
  • The molded body is intended to prevent feedback of the sound generated by the loudspeaker to the microphone as far as possible.
  • The molded body should be well tolerated by the skin, in particular it should allow ventilation of the skin of the ear canal and should not stimulate sweat and cerumen excretion.
  • The molded body should be insensitive to the excretions of the auditory canal and should be easy to clean from them, in particular it should also protect the electronic components of the hearing aid from these excretions.

Zu diesen Anforderungen, die die Funktion der Hörhilfe und deren Tragkomfort betreffen, kommen ökonomische Anforderungen derart, dass der Formkörper einfach herstellbar sein soll. Es könnte ebenfalls aus ökonomischen Gründen zusätzlich wünschbar sein, dass die elektronischen Bestandteile zugänglich in der Hörhilfe integriert sind, damit sie ausgewechselt werden können.To these requirements, the function of the hearing aid and its comfort concern, economic requirements come such that the molded body should be easy to manufacture. It could also be economic Reasons may also be desirable for the electronic components to be accessible are integrated in the hearing aid so that they can be replaced.

Den genannten Anforderungen genügen die bekannten, im Ohr zu tragenden Hörhilfen in verschiedenem Masse. Im folgenden sollen einige davon kurz beschrieben und mit der obigen Anforderungsliste verglichen werden.The known requirements to be worn in the ear meet the requirements mentioned Hearing aids of various sizes. Below are some of them briefly described and compared with the list of requirements above.

Die am häufigsten angewendete Methode zur Herstellung von im Ohr zu tragenden Hörhilfen besteht darin, dass durch einen Hörhilfenberater, der gleichzeitig die Hörschwächen des potentiellen Anwenders untersucht, ein Silikonabguss des Gehörganges hergestellt wird, dass nach diesem Silikonabguss ein transparentes, positives Modell des Gehörganges erstellt wird und dass in dieses Modell ein mit Hilfe von Licht polymerisierender Kunststoff gegossen wird, der von aussen nach innen bis zu einer bestimmten Schichtdicke härtet. Auf diese Art und Weise entsteht ein hohler Formkörper, in dem die elektronischen Bestandteile der Hörhilfe eingebaut werden, wobei gegen das Ohrinnere mindestens eine Öffnung für den Lautsprecher und für einen Druckausgleichskanal angeordnet werden. Gegen den Ausgang des Gehörganges wird der Formkörper mit einem Deckel abgeschlossen, der seinerseits eine Öffnung für den Druckausgleichskanal und ein separates Fach für eine auswechselbare Batterie enthält.The most common method of making in the ear too Wearing hearing aids consist of a hearing aid consultant who at the same time examines the hearing impairments of the potential user Silicone cast of the ear canal that is made after this silicone cast a transparent, positive model of the ear canal is created and that in this model a plastic polymerizing with the help of light is poured from the outside to the inside up to a certain layer thickness hardens. In this way, a hollow molded body is created, in which the electronic components of the hearing aid are installed, wherein at least one opening for the loudspeaker and for the inside of the ear a pressure equalization channel can be arranged. Against the exit of the The ear canal is closed with a lid that in turn an opening for the pressure equalization channel and a separate compartment for a replaceable battery.

Die derart hergestellte Hörhilfe weist einen Formkörper mit einer sehr guten Passform auf, wobei dieser aber die Haut des Gehörganges derart lückenlos abdeckt, dass von einer Belüftung nicht die Rede sein kann. Dies führt auch unweigerlich zu erhöhter Ausscheidung von Schweiss und Cerumen. Der zwischen Trommelfell und Hörhilfe frei bleibende Teil des Gehörganges ist durch den Druckausgleichskanal gegen aussen offen, sodass ein Druckausgleich stattfinden und auch Feuchtigkeit entweichen kann. Der Druckausgleichskanal kann aber seinerseits die Rückkoppelung zwischen Lautsprecher und Mikrophon erhöhen.The hearing aid produced in this way has a molded body with a very good one Fit, but the skin of the ear canal is so complete covers that there can be no question of ventilation. This also leads inevitably leads to increased excretion of sweat and cerumen. The between The eardrum and hearing aid remain part of the ear canal through the pressure equalization channel open to the outside, so that pressure equalization take place and moisture can escape. The pressure equalization channel But can in turn the feedback between speakers and raise the microphone.

Ein weiterer Nachteil dieser Hörhilfe besteht darin, dass sich die Öffnungen zu Lautsprecher und Druckausgleichskanal leicht mit Cerumen verstopfen können, wobei diese aber mit einer flüssigkeitsundurchlässigen aber gasdurchlässigen Membran abgedeckt sein können, wie dies gemäss der europäischen Patentanmeldung Nr.0310866 (publiziert 12.4.89) vorgeschlagen wird.Another disadvantage of this hearing aid is that the openings become closed Can easily clog the speaker and pressure equalization channel with cerumen, but with a liquid-impermeable but gas-permeable Membrane can be covered, as is the European Patent Application No. 0310866 (published April 12, 1989) is proposed.

Das beschriebene Verfahren zur Herstellung des Hörgerätes ist aufwendig, weil der Formkörper in mehreren positiv-negativ-Schritten gegossen werden muss und weil diese Herstellungsschritte derart sind, dass sie nicht vom Hörhilfenberater selbst ausgeführt werden können. Das heisst mit anderen Worten, der Hersteller der Hörhilfen muss sich mit der individuellen Fertigstellung einzelner, anwenderspezifischer Geräte befassen.The method described for producing the hearing aid is complex, because the molded body is cast in several positive-negative steps must and because these manufacturing steps are such that they are not provided by the hearing aid consultant can be run yourself. In other words, the manufacturer of the hearing aids has to deal with the individual completion of individual, user-specific devices.

Zur Vereinfachung des Herstellungsverfahrens sind verschiedene Vorschläge gemacht worden. Nach US-Patentschrift Nr. 4962537 wird beispielsweise vorgeschlagen, den Formkörper in Form eines doppelwandigen Sacks aus einem flexiblen Material vorzusehen, wobei direkt im Ohr des Anwenders zwischen die beiden Wandungen eine erhärtende Kunststoffmasse gepresst wird. Mit dieser Methode können einige Verfahrensschritte bei der Herstellung eingespart werden, aber der gegossene Formkörper muss trotzdem noch nachbearbeitet werden, insbesondere müssen an ihm eine Öffnungen für einen Druckausgleichskanal und für den Lautsprecher nachträglich angebracht werden, und es ist zweifelhaft, ob dies vom Hörhilfenberater selbst durchgeführt werden kann.There are several suggestions to simplify the manufacturing process been made. For example, U.S. Patent No. 4962537 proposes the molded body in the form of a double-walled sack from one to provide flexible material, directly in the user's ear between a hardening plastic mass is pressed on the two walls. With This method can save some manufacturing process steps but the cast molded body still has to be reworked , in particular an opening for a pressure compensation channel must be made on it and retrofitted for the speaker, and it is doubtful whether this will be done by the hearing aid advisor himself can.

Dasselbe gilt für die Hörhilfe gemäss der internationalen Patentanmeldung Nr. WO92/03894. Diese weist in ihrem noch nicht individualisierten Zustand eine Deckplatte auf, an der elektronische Bestandteile und ein als Druckausgleichskanal funktionierendes Rohr derart befestigt sind, dass sie in einem individuellen Gehörgang positionierbar sind. Zur Individualisierung wird die Hörhilfe in einem Gehörgang positioniert und dann eine erhärtende Giessmasse unter die Deckplatte eingebracht, derart, dass sie den Raum zwischen Gehörgangwand und Hörhilfeteilen ausfüllt und in erhärtetem Zustand der Hörhilfe einen an den individuellen Gehörgang angepassten Formkörper verleiht. Dieser Formkörper muss nach dem Giessen an seinem distalen Ende noch nachbearbeitet werden. The same applies to the hearing aid according to the international patent application No. WO92 / 03894. This shows in her not yet individualized Condition a cover plate on the electronic Components and a functioning as a pressure compensation channel Pipe are attached so that they are in an individual Ear canal are positionable. For individualization, the Hearing aid positioned in an ear canal and then one hardening casting compound introduced under the cover plate, in such a way that the space between the ear canal wall and hearing aid parts fills in and in the hardened state of the hearing aid to the gives shaped body adapted to individual ear canal. This Shaped body must still at its distal end after casting be reworked.

In der Publikation US-5131411 wird eine Hörhilfe beschrieben, die ebenfalls einen in einem individuellen Gehörgang erstellten Formkörper aufweist. Dieser wird hergestellt durch Aufschäumen eines schäumbaren Materials, das in der noch nicht individualisierten Hörhilfe in noch ungeschäumtem Zustand vorgesehen ist und das unmittelbar bevor die noch nicht individualisierte Hörhilfe in einem individuellen Gehörgang positioniert ist, zum Schäumen gebracht wird. Zur Verbesserung der Oberfläche der fertigen Hörhilfe kann zwischen Gehörgangwand und geschäumtem Formkörper eine feine Membran vorgesehen werden.Publication US-5131411 describes a hearing aid who also created one in an individual ear canal Has molded body. This is made by foaming of a foamable material that is not yet individualized Hearing aid is provided in an unfoamed state and that immediately before the not yet individualized hearing aid positioned in an individual ear canal to Foaming is brought. To improve the surface of the finished hearing aid can be between the ear canal wall and foamed Shaped body a fine membrane can be provided.

In der Publikation FR-2667500 wird die Herstellung eines Ohrpfropfens beschrieben. Der Ohrpfropfen wird hergestellt, indem ein an einer Deckplatte befestigter Giessstrumpf, in den ein Giesskanal führt, in einem individuellen Gehörgang positioniert wird und indem der Giessstrumpf durch den Giesskanal mit einer erhärtenden Giessmasse gefüllt wird. Der vom Giessstrumpf umgebene Formkörper nimmt dabei die Form des individuellen Gehörganges an. Der Ohrpfropfen kann als Gehörschutz verwendet werden oder nach dem Giessen mit einer Hörhilfeeinheit versehen und damit zu einem Hörgerät gemacht werden.The publication FR-2667500 describes the manufacture of an ear plug described. The earplug is made by a pouring stocking attached to a cover plate into which a Giesskanal leads, positioned in an individual ear canal and by pouring the casting stocking through the pouring channel with a hardening casting compound is filled. The one surrounded by the stocking Shaped body takes the shape of the individual ear canal on. The earplug can be used as hearing protection or provided with a hearing aid unit after casting and to be made into a hearing aid.

Die genannten Herstellungsverfahren sind zwar einfacher als das eingangs beschriebene Verfahren, verbessern aber die Nachteile bezüglich Hautkontakt und Rückkoppelung nicht. Dasselbe gilt für die Hörhilfe gemäss US Patent Nr. 4834211, bei der als Formkörper ein die elektronischen Bestandteile der Hörhilfe umgebender Ballon dient, der bei jedem Einführen ins Ohr mit einer entsprechenden Pumpe aufgeblasen wird. Bei einer solchen Hörhilfe sind wiederum Hautkontakt und Rückkoppelung nicht verbessert und es kann wohl nicht mehr von einfachem Einführen ins Ohr die Rede sein. The manufacturing processes mentioned are simpler than the beginning described methods, but improve the disadvantages with regard to skin contact and feedback is not. The same applies to the hearing aid according to US Patent No. 4834211, in which the electronic components as a molded body The balloon surrounding the hearing aid serves each time it is inserted into the ear is inflated with an appropriate pump. With such a hearing aid skin contact and feedback are not improved and it can probably no longer be a simple insertion into the ear.

Es ist nun die Aufgabe der Erfindung, eine im Ohr zu tragende Hörhilfe mit einem an einen individuellen Gehörgang angepassten Formkörper zu schaffen, wobei die Hörhilfe einerseits in Bezug auf den Tragkomfort gegenüber bekannten derartigen Hörhilfen Verbesserungen aufweist und andererseits in einem einfacheren Verfahren hergestellt, insbesondere individualisiert werden kann. Ferner ist ein Verfahren anzugeben, nach dem die Hörhilfe hergestellt, insbesondere individualisiert wird.It is now the object of the invention to have a hearing aid to be worn in the ear to create a molded body adapted to an individual ear canal, the hearing aid on the one hand in relation to comfort compared to known such hearing aids has improvements and on the other hand in a simpler process can be produced, in particular individualized can. Furthermore, a method must be specified by which the hearing aid is manufactured, especially individualized.

Das erfindungsgemässe Verfahren ist grob umrissen das folgende: Es wird serienmässig eine generelle (noch nicht an einen individuellen Gehörgang angepasste) Hörhilfe hergestellt. Diese weist ein vorteilhafterweise begrenzt plastisch verformbares Skelett auf, das die elektronischen Bestandteile der Hörhilfe trägt und an dem eine flexible Membran derart befestigt ist, dass durch Skelett und Membran ein Giessraum gebildet wird, der gegen aussen einen offenen Giesskanal aufweist. Die Hörhilfe wird nun individualisiert (an einen individuellen Gehörgang angepasste), indem das Skelett entsprechend der individuellen Gehörgangform verformt wird, indem die derart bereits teilweise individualisierte Hörhilfe im Ohr positioniert und dann der Giessraum mit einer erhärtenden Kunststoffmasse ausgegossen wird, wobei sich die Membran verformt und der entstehende Formkörper sich entsprechend dem Gehörgang formt. Dabei sind Skelett und Membran derart ausgebildet und aneinander befestigt, dass keine Nacharbeit der durch Skelettverformung und Giessen des Formkörpers individualisierten Hörhilfe notwendig ist.The method according to the invention is roughly outlined as follows: a general standard (not yet on an individual ear canal adapted) hearing aid. This advantageously has a limited plastically deformable skeleton on which the electronic components of the Hearing aid and to which a flexible membrane is attached such that a skeleton and membrane form a casting space that faces the outside has an open pouring channel. The hearing aid is now individualized (on customized an individual ear canal) by matching the skeleton the individual shape of the ear canal is deformed by already being so partially customized hearing aid positioned in the ear and then the casting room is poured out with a hardening plastic mass, the The membrane is deformed and the resulting molded body changes accordingly Ear canal shapes. The skeleton and membrane are designed and attached to each other that no reworking due to skeletal deformation and Pouring the molded body of individualized hearing aid is necessary.

Das Material und die Struktur der Membran sind derart, dass diese durch eine äusserst feine Porosität und entsprechende Oberflächenqualität für Gase durchlässig, für Flüssigkeiten aber undurchlässig ist und dass sie genügend elastisch ist, um sich beim Giessen des Formkörpers möglichst faltenfrei an die Gehörgangwand anlegen zu können. Die Membran ist dabei nicht nur senkrecht zu ihren Oberflächen gasdurchlässig sondern auch parallel dazu, derart, dass nicht nur durch diese Membran die beim Giessen verdrängte Luft entweichen kann, sondern dass sie auch als Druckausgleichsmittel und zur Belüftung der Gehörganghaut dienen kann. Diese Eigenschaft kann noch erhöht werden, indem die Membran an ihrer dem Skelett zugewandten Seite eine grober poröse Zwischenschicht trägt, die eine Schicht eines offenporigen Schaumstoffes oder ein Netz sein kann. Damit die Membran ihre Funktion auch langzeitig ausüben kann, ist sie zusätzlich wasser- und ölabstossend.The material and the structure of the membrane are such that they pass through an extremely fine porosity and corresponding surface quality for gases permeable, but impermeable to liquids and that they are sufficient is elastic in order to be as wrinkle-free as possible when casting the molded body to be able to put on the ear canal wall. The membrane is not just that perpendicular to their surfaces permeable to gas but also parallel to it, such that not only through this membrane the air displaced during casting can escape, but that they are also used as a pressure compensation and Ventilation of the ear canal skin can serve. This property can still be increased by the membrane on its side facing the skeleton a coarse porous intermediate layer that carries a layer of an open pore Foam or a network can be. So that the membrane functions can also exercise for a long time, it is also water and oil repellent.

Es zeigt sich, dass eine geschäumte und gereckte PTFE-Membran, die unter dem Namen GORE-TEX® von der Firma W.L. Gore & Co GmbH (D-88011 Putzbrunn bei München) hergestellt wird, die geforderten Eigenschaften aufweist und sich für die Anwendung eignet. Es handelt sich dabei um ein geschäumtes und gerecktes PTFE-Material (Polytetrafluoroethan), das eine feinst poröse Membran bildet. Diese Membran hat nicht nur die gefragten physikalischen Eigenschaften, sondern ist dazu sehr Haut- und Körper-freund-lich (sie kann auch als provisorische Haut bei grossflächigen Wunden verwendet werden).It turns out that a foamed and stretched PTFE membrane is under the name GORE-TEX® by W.L. Gore & Co GmbH (D-88011 Putzbrunn near Munich) is produced, which has the required properties and is suitable for use. It is a foamed one and stretched PTFE material (polytetrafluoroethane), the one finely porous membrane. This membrane has not only the ones in demand physical properties, but is very skin and body friendly (It can also be used as a temporary skin for large wounds become).

Als weitere Membranmaterialien sind aus Kunststoffasern beispielsweise gewebte, gestrickte oder gewirkte Materialien denkbar, die mindestens auf der dem Gehörgang zugewandten Oberfläche beschichtet sind mit einer öl- und wasserabstossenden Schicht. Diese Schicht kann beispielsweise eine aufgedampfte Schicht von Parylen® (Union Carbide Corp., USA) oder Silan sein.As further membrane materials are woven from plastic fibers, for example, knitted or knitted materials conceivable that at least on the the surface facing the ear canal are coated with an oil and water repellent layer. This layer can, for example, be vapor-deposited Layer of Parylen® (Union Carbide Corp., USA) or silane.

Anhand der folgenden Figuren sollen nun das erfindungsgemässe Herstellungsverfahren und die nach dem Verfahren hergestellte Hörhilfe anhand einiger beispielhafter Ausführungsformen detailliert beschrieben werden. Dabei zeigen:

Figur 1
ein Schema der wichtigsten Teile der erfindungsgemässen Hörhilfe zur Erklärung ihrer Funktionen (Schnitt parallel zur Gehörgangachse);
Figur 2
eine beispielhafte Ausführungsform der erfindungsgemässen individualisierten Hörhilfe, parallel zur Gehörgangachse geschnitten;
Figuren 3 und 4
eine weitere, beispielhafte Ausführungsform der erfindungsgemässen Hörhilfe in generellem Zustand (Figur 3 und unmittelbar vor dem Giessen des Formkörpers);
Figuren 5a bis 5c
verschiedene Verfahren zur Herstellung eines Membransackes für die erfindungsgemässe Hörhilfe.
Using the following figures, the manufacturing method according to the invention and the hearing aid manufactured according to the method will now be described in detail using some exemplary embodiments. Show:
Figure 1
a diagram of the most important parts of the hearing aid according to the invention to explain their functions (section parallel to the auditory canal axis);
Figure 2
an exemplary embodiment of the individualized hearing aid according to the invention, cut parallel to the auditory canal axis;
Figures 3 and 4
a further, exemplary embodiment of the hearing aid according to the invention in a general state (FIG. 3 and immediately before the molding is cast);
Figures 5a to 5c
Various methods for producing a membrane bag for the hearing aid according to the invention.

Figur 1 zeigt das Prinzip der erfindungsgemässen Hörhilfe in einer sehr schematischen Art und Weise. Die Hörhilfe ist dabei in ihrem bereits individualisierten Zustand und parallel zur Achse des Gehörganges geschnitten dargestellt. Sie hat im wesentlichen die Form eines unregelmässigen Kegelstumpfes mit einer Mantelfläche M, einer im Gehörgang gegen aussen gerichteten, grösseren Stirnseite AS und einer im Gehörgang gegen innen gewandten, kleineren Stirnseite IS. Figure 1 shows the principle of the hearing aid according to the invention in a very schematic manner. The hearing aid is shown cut in its already individualized state and parallel to the axis of the auditory canal. It essentially has the shape of an irregular truncated cone with a lateral surface M, a larger end face AS directed towards the outside in the auditory canal and a smaller end face IS facing towards the inside in the auditory canal.

Die Hörhilfe besteht im wesentlichen aus einem Formkörper 1, der in seiner Form dem Gehörgang angepasst ist und mindestens auf der Mantelfläche M, das heisst da, wo er die Gehörgangwand beim Tragen des Gerätes berührt, wie bereits beschrieben mit einer Membran 2 überdeckt ist. Die Hörhilfe besitzt ferner ein Skelett, das im wesentlichen aus drei Teilen besteht: aus einem äusseren Tragelement 3, das im wesentlichen die äussere Stirnseite AS des Gerätes bildet, einem inneren Tragelement 4, das im wesentlichen die innere Stirnfläche des Gerätes bildet, und einem Verbindungselement 5, das die beiden Tragelemente 3 und 4 miteinander verbindet. Das Verbindungselement 5 dient dazu, die beiden Tragelemente 3 und 4 vor dem Giessen des Formkörpers in einer gegenseitigen Lage zu halten, die grob einem Gehörgang entspricht. Das Verbindungselement 5 ist dabei vorteilhafterweise beschränkt deformierbar, sodass als erster Individualisierungsschritt die gegenseitige Lage der Tragelemente 3 und 4 dem individuellen Gehörgang angepasst werden kann.The hearing aid consists essentially of a molded body 1, which in its Shape is adapted to the ear canal and at least on the lateral surface M, that means where he touches the ear canal wall while wearing the device, is covered with a membrane 2 as already described. The hearing aid also has a skeleton consisting essentially of three parts: of an outer support element 3, which essentially the outer end face AS the device forms an inner support member 4, which is essentially the forms the inner end face of the device, and a connecting element 5, the connects the two support elements 3 and 4 together. The connecting element 5 serves to support the two support elements 3 and 4 before casting the To keep the shaped body in a mutual position, the roughly an ear canal corresponds. The connecting element 5 is advantageously limited deformable, so that the first individualization step is the mutual Position of the support elements 3 and 4 adapted to the individual ear canal can be.

Das äussere Tragelement 3 trägt ein Mikrophon 31, für das es an der entsprechenden Stelle mit Schalldurchtrittsöffnungen 32 versehen ist. Ferner bildet das äussere Tragelement 3 ein verschliessbares Batteriefach 33 und trägt eine Eingiess- oder Einspritzöffnung 34.The outer support element 3 carries a microphone 31, for which it is connected to the corresponding Place is provided with sound passage openings 32. Furthermore forms the outer support element 3 has a lockable battery compartment 33 and carries one Pouring or injection opening 34.

Das innere Tragelement 4 trägt einen Lautsprecher 41 und ist ebenfalls mit Schalldurchtrittsöffnungen 42 versehen.The inner support element 4 carries a loudspeaker 41 and is also included Sound passage openings 42 provided.

Die Membran 2, die den Formkörper mindestens auf seiner Mantelfläche M umgibt, ist rund um die beiden Stirnseiten AS und IS an den beiden Tragelementen befestigt (Stellen X in der Figur). Die Membran 2 kann zusätzlich die innere Stirnfläche IS ganz überspannen. Sie kann auch die äussere Stirnfläche teilweise überspannen, muss aber die Eingiess- oder Einspritzöffnung 34 und das Batteriefach 33 frei zugänglich lassen.The membrane 2, which the molded body at least on its lateral surface M surrounds, is around the two end faces AS and IS on the two support elements attached (digits X in the figure). The membrane 2 can additionally completely span the inner end face IS. You can also use the outer face partially spanning, but must the pouring or injection opening 34 and leave the battery compartment 33 freely accessible.

Die Verstärkerelektronik (nicht dargestellt) kann entweder von einem der Tragelemente oder vom Verbindungselement getragen werden. Sie kann auch ohne spezielle Befestigung am Skelett in den Formkörper eingegossen sein. The amplifier electronics (not shown) can either be from one of the Carrying elements or worn by the connecting element. It can too be cast into the molded body without special attachment to the skeleton.

Das Skelett besteht vorteilhafterweise aus Kunststoff. Die Membran kann an den Tragelementen beispielsweise durch Schweissung, durch Kleben oder durch entsprechende Spannelemente befestigt sein. Weitere Befestigungsmöglichkeiten werden im Zusammenhang mit den Figuren 2 bis 4 beschrieben.The skeleton is advantageously made of plastic. The membrane can the supporting elements, for example by welding, by gluing or be fastened by appropriate tensioning elements. Other mounting options are described in connection with Figures 2 to 4.

Die generelle Hörhilfe, aus der die in der Figur 1 schematisch dargestellte, individualisierte Hörhilfe hergestellt wird, unterscheidet sich von dieser dadurch, dass der Formkörper 1 nur als noch unbestimmter Giessholraum zwischen Tragelementen und Membran vorhanden ist. Die an den Tragelementen 3 und 4 befestigte Membran 2 umgibt also das Skelett locker und bildet mit den Tragelementen zusammen einen das Skelett im wesentlichen rohrförmig umgebenden Giessraum, der sich durch den Giesskanal 34 gegen aussen öffnet.The general hearing aid, from which the one shown schematically in FIG. individualized hearing aid, differs from this in that that the molded body 1 only as an undetermined casting cavity between Support elements and membrane is present. The on the support elements 3 and 4 attached membrane 2 surrounds the skeleton loosely and forms the supporting elements together form a substantially tubular skeleton surrounding casting room, which opens through the pouring channel 34 to the outside.

Der Giessraum zwischen Membran und Skelett wird durch den Giesskanal 34 mit einem geeigneten Kunststoff ausgegossen, während die Hörhilfe im Gehörgang positioniert ist. Der Kunststoff erhärtet zum individualisierten Formkörper 1. Die Anforderungen an den Kunststoff sind, dass er einfach durch den Giesskanal eingegossen werden kann und dass er schnell aushärtet. Selbstverständlich muss er hautverträglich sein.The casting space between the membrane and the skeleton is through the pouring channel 34 Poured out with a suitable plastic while the hearing aid is in the ear canal is positioned. The plastic hardens to an individualized molded body 1. The requirements for the plastic are that it is easy to get through the pouring channel can be poured in and that it hardens quickly. Of course, it must be skin-friendly.

Es zeigt sich, dass die von der Firma 3M unter dem Namen Imprint® hergestellte, vor allem in der Dentaltechnik angewendete Giessmasse auf der Basis von Vinylpolysiloxan für die vorliegende Anwendung sehr geeignet ist. Diese Zweikomponenten-Giessmasse ist in einfach handhabbaren Zwillingskartuschen mit Mischkanülen erhältlich, die direkt auf den Giesskanal 34 aufgesetzt werden können. It can be seen that the 3M company manufactured under the name Imprint® based mainly on the molding compound used in dental technology of vinyl polysiloxane is very suitable for the present application. This Two-component casting compound is in easy-to-use twin cartridges available with mixing tips that are placed directly on the pouring channel 34 can be.

Selbstverständlich lassen sich auch andere Giessmassen verwenden. Vorteilhafterweise werden derartige Materialien angewendet, die bei der Polymerisation keine niedermolekularen Reste abspalten. Der Giessmasse können zur Verbesserung der Eigenschaften des Formkörpers als Schall- und Vibrationsdämpfer Zusätze, beispielsweise kleine Schaumstoffkörper oder hohle Glaskugeln, zugesetzt werden.Of course, other casting compounds can also be used. Advantageously such materials are used in the polymerization do not split off any low molecular weight residues. The casting compound can Improvement of the properties of the molded body as a sound and vibration damper Additives, for example small foam bodies or hollow glass balls, be added.

Während dem Giessvorgang, insbesondere auch während der letzten Phasen dieses Giessvorganges, wenn der Formkörper bereits stark an der Gehörgangwand anliegt, findet durch die Membran und die Zwischenschicht, wenn eine solche vorgesehen ist, parallel zu deren Hauptflächen ein Druckausgleich statt, sodass sich durch das Giessen im durch den Formkörper abgeschlossenen Gehörgang kein Druck aufbauen kann.During the casting process, especially during the last phases this casting process when the molded body is already strongly on the ear canal wall is present through the membrane and the intermediate layer, if one such is provided, a pressure equalization parallel to their main surfaces instead, so that the molding is closed off by the molding Ear canal build up no pressure.

Die Herstellung der in der Figur 1 schematisch dargestellten Hörhilfe geht nun beispielsweise in den folgenden Schritten vor:

  • Skelett herstellen, beispielsweise durch Spritzgiessen eines geeigneten Kunststoffes.
  • Lautsprecher 41, Mikrophon 31 und Verstärkerelektronik am Skelett installieren und elektrisch miteinander und mit dem Batteriefach 33 verbinden.
  • Skelett mit der Membran 2 umgeben und diese an den Tragelementen 3 und 4 befestigen (Stellen X).
  • Die in den ersten drei Schritten hergestellte generelle Hörhilfe durch entsprechende Deformation des Skeletts bzw. des Verbindungselementes 5 grob an einen individuellen Gehörgang anpassen.
  • Grob angepasste Hörhilfe im Gehörgang positionieren und Formkörper durch Ausgiessen des Giessraums zwischen Membran und Skelett herstellen.
  • Batterie einsetzen.
The production of the hearing aid shown schematically in FIG. 1 now proceeds, for example, in the following steps:
  • Create a skeleton, for example by injection molding a suitable plastic.
  • Install loudspeaker 41, microphone 31 and amplifier electronics on the skeleton and connect them electrically to one another and to the battery compartment 33.
  • Surround the skeleton with the membrane 2 and attach it to the support elements 3 and 4 (positions X).
  • Roughly adapt the general hearing aid produced in the first three steps to an individual auditory canal by appropriately deforming the skeleton or the connecting element 5.
  • Position the roughly adapted hearing aid in the ear canal and produce the molded body by pouring the casting space between the membrane and the skeleton.
  • Insert the battery.

Die zur Individualisierung der generellen Hörhilfe notwendigen Schritte sind das Verformen des Skeletts und das Giessen des Formkörpers. Beide Schritte können ohne Probleme vom Hörhilfenberater durchgeführt werden, derart, dass der Anwender die Hörhilfe nach einer Session mitnehmen kann und dass der Fabrikant lediglich generelle Hörhilfen herstellen muss.The steps necessary to individualize the general hearing aid are deforming the skeleton and casting the molded body. Both steps can be performed by the hearing aid consultant without any problems, such as that the user can take the hearing aid with them after a session and that the manufacturer only has to produce general hearing aids.

Die in den Figuren 2 bis 4 dargestellten, beispielhaften Ausführungsformen der erfindungsgemässen Hörhilfe unterscheiden sich voneinander im wesentlichen dadurch dass die elektronischen Bestandteile in verschiedenem Masse zugänglich sind. Das im Zusammenhang mit der Figur 1 beschriebene Prinzip ist in allen Ausführungsformen erhalten.The exemplary embodiments shown in FIGS. 2 to 4 The hearing aid according to the invention essentially differ from one another in that the electronic components to different degrees are accessible. The principle described in connection with Figure 1 is preserved in all embodiments.

Figur 2 zeigt eine erste beispielhafte Ausführungsform der erfindungsgemässen Hörhilfe wiederum im Schnitt parallel zur Gehörgangachse. Das Gerät ist in einem Gehörgang positioniert, wobei die Gehörgangwände mit den Linien G angedeutet sind. Die dargestellte Hörhilfe ist bereits individualisiert. Sie besitzt ein Skelett, das wiederum aus einem äusseren Tragelement 3, einem inneren Tragelement 4 und einem Verbindungselement 5 besteht und das die elektronischen Bestandteile trägt. Dieses Skelett ist in einem gegossenen Formkörper 1 angeordnet, dessen gegen den Gehörgang gerichtete Oberfläche von einer sackförmigen Membran 2 bedeckt ist. FIG. 2 shows a first exemplary embodiment of the hearing aid according to the invention, again in section parallel to the auditory canal axis. The device is positioned in an auditory canal, the auditory canal walls being indicated by the lines G. The hearing aid shown is already individualized. It has a skeleton, which in turn consists of an outer support element 3, an inner support element 4 and a connecting element 5 and which carries the electronic components. This skeleton is arranged in a cast molded body 1, the surface of which facing the auditory canal is covered by a sack-shaped membrane 2.

Die beiden Tragelemente 3 und 4 sind als eine innere Kapsel 4.1 mit einem inneren Schliesselement 4.2 und eine äussere Kapsel 3.1 mit einem äusseren Schliesselement 3.2 ausgebildet, durch die eine wenigstens teilweise Zugänglichkeit der elektronischen Bestandteile an der individualisierten Hörhilfe möglich wird.The two support elements 3 and 4 are designed as an inner capsule 4.1 with a inner closing element 4.2 and an outer capsule 3.1 with an outer Locking element 3.2 formed, through the at least partial accessibility of the electronic components on the individualized hearing aid becomes possible.

In der inneren Kapsel 4.1 ist der Lautsprecher 41 untergebracht, der durch deren Öffnung eingeführt wird, bevor das Schliesselement 4.2 darauf gesetzt wird. In der äusseren Kapsel 3.1 sind vorteilhafterweise in entsprechend angeordneten Fächern das Mikrophon 31 in einem Mikrophonfach 31.1 und in einem Batteriefach 33 eine Batterie untergebracht. Auch die Verstärkerelektronik 6 kann in der äusseren Kapsel 3.1 untergebracht sein. Die elektrischen Verbindungen zwischen den elektronischen Bestandteilen der Hörhilfe verlaufen beispielsweise durch das deformierbare Verbindungselement 5.In the inner capsule 4.1, the speaker 41 is housed by the opening of which is introduced before the closing element 4.2 is placed on it becomes. In the outer capsule 3.1 are advantageously arranged accordingly Fan the microphone 31 in a microphone compartment 31.1 and in a battery compartment 33 accommodates a battery. The amplifier electronics too 6 can be accommodated in the outer capsule 3.1. The electrical Connections between the electronic components of the hearing aid run for example by the deformable connecting element 5.

Im Bereiche der äusseren Kapsel 3.1 und ebenfalls gegen aussen offen ist auch der Giesskanal (Eingiessöffnung) 34 angeordnet, beispielsweise an der äusseren Kapsel 3.1 angeformt. Die Öffnungen der einzelnen Fächer der äusseren Kapsel 3.1 und die Öffnung des Giesskanales 34 liegen vorteilhafterweise im wesentlichen in einer Ebene, sodass sie gemeinsam vom Schliesselement 3.2 geschlossen werden können. Es können für die verschiedenen Öffnungen aber auch separate Schliesselemente vorgesehen sein oder für einzelne der Öffnungen Teilbereiche des gemeinsamen Schliesselementes 3.2 derart ausgestaltet sein, dass sie geöffnet und geschlossen werden können, ohne dass das ganze Schliesselement 3.2 geöffnet werden muss. In der Figur 2 ist das Batteriefach 33 mit einem derartigen Teilschliesselement 33.1 abgeschlossen und dadurch für den Anwender sehr einfach zugänglich.In the area of the outer capsule 3.1 and also open to the outside the pouring channel (pouring opening) 34 is also arranged, for example on the outer capsule 3.1 molded. The openings of the individual compartments of the outer capsule 3.1 and the opening of the pouring channel 34 advantageously lies essentially in one level, so that they are closed together by the locking element 3.2 can. It can also be separate for the different openings Closing elements may be provided or partial areas for individual openings of the common locking element 3.2 can be designed such that they can be opened and closed without the whole locking element 3.2 must be opened. The battery compartment 33 is shown in FIG completed such a partial closing element 33.1 and thereby for the Easily accessible to users.

Die sackförmige Membran 2 besitzt eine Hauptöffnung, deren Kante rund um den Bereich, in dem die Öffnung der äusseren Kapsel 3.1 und die Öffnung des Giesskanals 34 angeordnet sind, derart befestigt ist, dass das ganze Skelett im wesentlichen bis auf die Öffnung des Giesskanales 34 und die Öffnung der äusseren Kapsel 3.1 durch die Membran 2 umschlossen ist. Die Befestigung der Membran 2 rund um die äussere Kapsel wird übernommen durch ein äusseres Membranfixiermittel, das beispielsweise aus einem formschlüssig um die äussere Kapsel angeordneten Fixierring 10 (auf der linken Seite der Figur dargestellt) oder durch entsprechend formschlüssige Ausgestaltung der Randbereiche des Schliesselementes 3.2 (auf der rechten Seite der Figur dargestellt) bestehen kann. Wird die Membran 2 durch das Schliesselement 3.2 an der äusseren Kapsel 3.1 befestigt, ist es notwendig, dass das Schliesselement 3.2, wie dies in der Figur für das Batteriefach 33 dargestellt ist, auch für den Giesskanal 34 einen entfernbaren Teilbereich oder mindestens eine Öffnung aufweist.The sack-shaped membrane 2 has a main opening, the edge of which is all around the area in which the opening of the outer capsule 3.1 and the opening of the Giesskanals 34 are arranged such that the entire skeleton in the except for the opening of the pouring channel 34 and the opening of the outer capsule 3.1 is enclosed by the membrane 2. The attachment the membrane 2 around the outer capsule is taken over by a outer membrane fixative, for example, from a form-fitting order the outer capsule arranged fixing ring 10 (on the left side of the figure shown) or by appropriately form-fitting design of the edge areas of the closing element 3.2 (shown on the right side of the figure) can exist. If the membrane 2 through the closing element 3.2 attached to the outer capsule 3.1, it is necessary that the closing element 3.2, as shown in the figure for the battery compartment 33, also for the Pour channel 34 a removable portion or at least one opening having.

Rund um die Öffnung der inneren Kapsel 4.1 ist die Membran 2 mit einem inneren Membranfixiermittel befestigt, wobei sie die Lautsprecheröffnung überspannen (wie dargestellt) oder in diesem Bereiche eine weitere Öffnung aufweisen kann. Das innere Membranfixiermittel ist beispielsweise das formschlüssig auf die Öffnung der inneren Kapsel 4.1 passende, perforierte innere Schliesselement 4.2, das die Membran 2 rund um die Öffnung der Kapsel 4.1 derart festhält, dass die Giessmasse nicht in die Öffnung treten kann, das den die Kapselöffnung überspannenden Teil 21 der Membran 2 im Gebrauch mechanisch schützt und das für den Schall des Lautsprechers aber kein Hindernis darstellt (Schalldurchtrittsöffnungen).Around the opening of the inner capsule 4.1 is the membrane 2 with a inner membrane fixer attached, opening the speaker span (as shown) or another opening in this area can have. The inner membrane fixing agent is, for example, the form-fitting perforated inner fitting to the opening of the inner capsule 4.1 Closing element 4.2, the membrane 2 around the opening of the capsule 4.1 holds in such a way that the casting compound cannot enter the opening, which the the capsule opening spanning part 21 of the membrane 2 in use protects mechanically and that is not an obstacle to the sound of the speaker represents (sound passage openings).

Auch derjenige Teil der Öffnung der äusseren Kapsel 3.1, der über dem Mikrophonfach 31.1 liegt, kann mit einer Membran abgedeckt sein. Dies kann, wie in der Figur 1 dargestellt, mit einem zwischen Schliesselement 4.2 und Kapselwand eingeklemmten, separaten Stück 22 der Membran realisiert werden oder aber derart, dass die Membran 2 sich einstückig auch über diese Öffnung spannt, wobei sie in gleicher Weise festgehalten wird wie an der Öffnung der inneren Kapsel 4.1. Im das Mikrophonfach 31.1 überdeckenden Bereich ist das Schliesselement 3.2 vorteilhafterweise perforiert.That part of the opening of the outer capsule 3.1 that is above the microphone compartment 31.1 is covered with a membrane. This can, as shown in Figure 1, with a between closing element 4.2 and Capsule wall clamped, separate piece 22 of the membrane can be realized or in such a way that the membrane 2 also integrally over it Opening spans, being held in the same way as on the Opening the inner capsule 4.1. In the one covering the microphone compartment 31.1 Area, the closing element 3.2 is advantageously perforated.

Die Membran 2 kann an den Kapseln oder den entsprechenden Schliesselementen wie bereits erwähnt auch angeschweisst oder angeklebt sein.The membrane 2 can on the capsules or the corresponding closing elements As already mentioned, it can also be welded or glued on.

Figuren 3 und 4 zeigen eine weitere Ausführungsform der erfindungsgemässen Hörhilfe. Das Prinzip entspricht wiederum dem im Zusammenhang mit der Figur 1 beschriebenen und auch die prinzipiellen Bestandteile der Hörhilfe sind dieselben, sodass beides nicht mehr beschrieben werden muss. Der Unterschied zu den Hörhilfen gemäss Figuren 1 und 2 besteht darin, dass das Verbindungselement 5 hohl ist und als Druckausgleichskanal dient, wozu im inneren (4) und im äusseren Tragelement 3 korrespondierende Mündungsöffnungen 45 und 35 vorgesehen sind. Ferner ist die Eingiessöffnung 34 derart angeordnet, dass sie ins Batteriefach 33 mündet. Die innere Stirnseite IS ist mit einem separaten Membranstück 46, der Bereich des Mikrophons 31 und der äusseren Mündungsöffnung 45 des Druckausgleichskanals mit einem separaten Membranstück 36 bedeckt. Mikrophon 31 und Lautsprecher 41 werden direkt von der Giessmasse umgossen oder können formkörperseitig mit einem Schallisolationsmaterial 37 umgeben sein. Figures 3 and 4 show a further embodiment of the hearing aid according to the invention. The principle in turn corresponds to that described in connection with FIG. 1 and the basic components of the hearing aid are the same, so that both no longer need to be described. The difference from the hearing aids according to FIGS. 1 and 2 is that the connecting element 5 is hollow and serves as a pressure compensation channel, for which purpose corresponding mouth openings 45 and 35 are provided in the inner (4) and in the outer supporting element 3. Furthermore, the pouring opening 34 is arranged such that it opens into the battery compartment 33. The inner end face IS is covered with a separate membrane piece 46, the area of the microphone 31 and the outer mouth opening 45 of the pressure compensation channel with a separate membrane piece 36. Microphone 31 and loudspeaker 41 are cast directly by the casting compound or can be surrounded on the molded body side with a sound insulation material 37.

Figur 3 zeigt die Hörhilfe in generellem Zustand, wie sie vom Hersteller abgeliefert wird. FIG. 3 shows the hearing aid in the general state as it is delivered by the manufacturer.

Figur 4 zeigt die Hörhilfe im Gehörgang G, bereit zum Ausgiessen. Um die Eingiessöffnung 34 frei zu geben, sind Batterie und Batteriefachdeckel entfernt. Um die Mündungsöffnungen 35 und 45 des Druckausgleichskanals freizugeben, sind die separaten Membranstücke 36 und 46 (Fig. 3) entfernt, und durch den Druckausgleichskanal mit einem Draht 7 befestigt ist auf der inneren Stirnseite IS der Hörhilfe ein Schutzelement 48 angebracht, durch das nicht nur das Trommelfell beim Giessen geschützt werden soll, sondern das auch helfen soll, die noch nicht individualisierte Hörhilfe im Gehörgang zu positionieren. Das Schutzelement 48 besteht beispielsweise aus Schaumstoff. Der das Schutzelement tragende Draht 7 kann zusätzlich als Hilfe zum Einführen der Hörhilfe in den Gehörkanal und zu dessen Entfernung dienen. Figure 4 shows the hearing aid in the ear canal G, ready for pouring. In order to open the pouring opening 34, the battery and the battery compartment cover are removed. In order to expose the orifices 35 and 45 of the pressure equalization channel, the separate membrane pieces 36 and 46 (FIG. 3) are removed, and a protective element 48 is attached to the inner end face IS of the hearing aid through the pressure equalization channel with a wire 7, through which not only the eardrum should be protected during casting, but should also help to position the not yet individualized hearing aid in the ear canal. The protective element 48 consists for example of foam. The wire 7 carrying the protective element can additionally serve as an aid for inserting the hearing aid into the auditory canal and for removing it.

Die Membran muss vor dem Ausgiessen, also im generellen Zustande der Hörhilfe bereits eine einigermassen dem Gehörgang entsprechende Form aufweisen, damit sie den Formkörper im individualisierten Zustand der Hörhilfe faltenfrei umspannt. Insbesondere sollte sie rund um ihre Hauptöffnung (äussere Stirnseite) und rund um die Öffnung an der inneren Stirnseite möglichst faltenfrei befestigt werden können. Dazu muss die Membran in Form eines sich von der Hauptöffnung weg verjüngenden Sacks vorliegen. Ein derartiger Membransack kann, wie in den Figuren 5a bis 5c dargestellt, auf verschiedene Arten hergestellt werden.Before pouring, that is to say in the general state of the hearing aid, the membrane must already have a shape corresponding to a certain extent to the auditory canal, so that in the individualized state of the hearing aid it spans the molded body without wrinkles. In particular, it should be possible to attach it around its main opening (outer end face) and around the opening on the inner end face as wrinkle-free as possible. To do this, the membrane must be in the form of a sack that tapers away from the main opening. Such a membrane bag can, as shown in FIGS . 5a to 5c , be produced in different ways.

Bei genügender Verformbarkeit der Membran kann ein derartiger Sack S, wie dies in der Figur 5a dargestellt ist, aus einem flachen Stück ME einer Membran gezogen werden. Diese Herstellungsweise bedingt eine genügende Verformbarkeit der Membran, ist aber insbesondere vorteilhaft, wenn die innere stirnseite der Hörhilfe von der Membran überspannt werden soll, das heisst, wenn der Membransack nur eine Hauptöffnung aber keine weitere Öffnung aufweisen soll.If the membrane is sufficiently deformable, such a bag S, as shown in FIG. 5a , can be drawn from a flat piece ME of a membrane. This method of manufacture requires sufficient deformability of the membrane, but is particularly advantageous if the membrane is to span the inner end face of the hearing aid, that is to say if the membrane bag is to have only one main opening but no further opening.

Figur 5b zeigt ein Verfahren zur Herstellung eines Membransackes S ebenfalls aus einem ebenen Membranstück ME, aus dem ein Stück K in der Form eines abgewickelten Kegelstumpfmantels geschnitten wird. Dieses Stück K wird zum Membransack S mit einer Hauptöffnung H und einer weiteren Öffnung W geschweisst. FIG. 5b shows a method for producing a membrane bag S, likewise from a flat membrane piece ME, from which a piece K is cut in the form of a unwound truncated cone. This piece K is welded to the membrane bag S with a main opening H and a further opening W.

Figur 5c zeigt die Herstellung eines Membransackes wiederum mit Hauptöffnung H und weiterer Öffnung W aus einem Stück Membranschlauch MS durch Ausweitung seines einen Endes auf einen grösseren Durchmesser. FIG. 5c shows the production of a membrane bag again with a main opening H and a further opening W from a piece of membrane hose MS by expanding its one end to a larger diameter.

Um den Gasaustausch in der Richtung der Hauptflächen der Membran zu unterstützen, kann, wie bereits erwähnt, diese auf eine zweite Schicht (Zwischenschicht) aufgezogen sein, die an der fertigen Hörhilfe zwischen der Membran und dem Formkörper angeordnet ist, also nicht mit der Haut des Gehörganges in Berührung kommt. Diese Schicht kann, wie bereits erwähnt ein offenporiger Schaumstoff oder ein Netz sein, auf die die Membran aufgezogen ist. Es zeigt sich, dass eine derartige Zwischenschicht auch die Herstellung des Membransackes erleichtern kann.To allow gas exchange in the direction of the main surfaces of the membrane support, as already mentioned, this on a second layer (intermediate layer) be brought up on the finished hearing aid between the Membrane and the molded body is arranged, so not with the skin of the Ear canal comes into contact. As already mentioned, this layer can be an open-cell foam or a mesh on which the membrane is drawn is. It turns out that such an intermediate layer is also used in production of the membrane bag.

Claims (15)

  1. Hearing aid to be worn in the ear which hearing aid essentially corresponds to an irregular frustum with an outer end face (AS), an inner end face (IS) and a circumferential surface (M), which hearing aid comprises a skeleton with an outer support element (3) and a connecting element (5), the outer support element (3) forming the outer end face (AS) and having a pouring opening (34) and the connecting element (5) connecting the outer end face (AS) with the inner end face (IS), which hearing aid comprises electronic components at least partly carried by the skeleton and which hearing aid is adaptable or adapted to an individual auditory canal by means of moulding of a shaped member, characterized in that the skeleton additionally comprises an inner support element (4) forming the inner end face (IS) and that a microporous diaphragm (2) is fixed to the support elements (3, 4) in such a manner that it forms the circumferential surface (M) of the frustum and, for the adaptable hearing aid, limits together with the skeleton (3, 4, 5) a moulding chamber and, for the adapted hearing aid limits the shaped member (1) moulded in the moulding chamber, wherein the microporous diaphragm (2) is permeable for gases in directions perpendicular and parallel to its surface and impermeable for liquids and wherein the microporous diaphragm (2) is oil and water-repellent for maintaining the wearing comfort achieved by its porosity.
  2. Hearing aid according to claim 1, characterized in that the diaphragm (2) is a foamed and stretched PTFE material.
  3. Hearing aid according to claim 1, characterized in that the microporous diaphragm (2) is woven or knitted from plastic fibers and is coated with a water or oil-repellent layer at least on the side facing the auditory canal.
  4. Hearing aid according to one of the claims 1 to 3, characterized in that the microporous diaphragm (2) carries an intermediate layer on its side facing the skeleton (3, 4, 5).
  5. Hearing aid according to claim 4, characterized in that the intermediate layer comprises an open-pore foam or a gauze.
  6. Hearing aid according to one of claims 1 to 5, characterized in that, in the case of the adapted hearing aid comprising a shaped member, said shaped member (1) consists at least partly of polysiloxane.
  7. Hearing aid according to one of claims 1 to 6, characterized in that, in the case of the adapted hearing aid comprising a shaped member, said shaped member (1) comprises additives for improving its absorbing characteristics.
  8. Hearing aid according to claim 7, characterized in that the additives are foam pieces or hollow glass balls.
  9. Hearing aid according to one of claims 1 to 8, characterized in that the inner end face (IS) is wholly or partly covered and/or the outer end face (AS) is partly covered by the microporous diaphragm (2).
  10. Hearing aid according to one of the claims 1 to 9, characterized in that at least one of the support elements (3, 4) is designed as a capsule (3.1, 4.1) with a closing element (3.2, 4.2).
  11. Hearing aid according to one of the claims 1 to 10, characterized in that the microporous diaphragm (2) is fixed to the support elements (3, 4) by welding, by gluing or by a diaphragm fixing means.
  12. Hearing aid according to one of the claims 1 to 11, characterized in that the connecting element (5) is plastically deformable.
  13. Hearing aid according to one of the claims 1 to 12, characterized in that the connecting element (5) is hollow and that the support elements (3, 4) comprise openings (35, 45) which, together with the cavity of the connecting element, form a pressure compensating channel.
  14. Method for individualizing a hearing aid according to one of claims 1 to 13, wherein a hearing aid not yet comprising a shaped member (1) is positioned in an individual auditory canal of a wearer and a hardening moulding material is poured through the pouring opening (34) around the skeleton (3, 4, 5) of the hearing aid positioned in the auditory canal, which moulding material hardens in the auditory canal, characterized in that when filling the substantially tubular moulding chamber limited by the skeleton (3, 4, 5) and the microporous diaphragm (2), the diaphragm (2) is positioned against the wall of the auditory canal, wherein air displaced by the moulding process from the moulding chamber and from the auditory canal is at least partly removed through the microporous diaphragm (2) being permeable for gases perpendicular and parallel to its surface.
  15. Method according to claim 14, characterized in that prior to the moulding process the hearing aid is roughly adapted to the individual auditory canal by means of plastic deformation of the connecting element (5) of the skeleton (3, 4, 5).
EP94810287A 1993-06-11 1994-05-17 Hearing aid to be worn in the ear and method for manufacturing the same Expired - Lifetime EP0629101B1 (en)

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CH1757/93 1993-06-11
CH175793 1993-06-11
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EP0629101A1 (en) 1994-12-14
AU6332694A (en) 1994-12-15
US5530763A (en) 1996-06-25
DK0629101T3 (en) 2001-12-31
DE59409849D1 (en) 2001-10-11
AU677647B2 (en) 1997-05-01
ATE205357T1 (en) 2001-09-15

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