Patent Grant
10897676
The present invention relates to a device for insertion of a hearing aid into an ear canal of an individual user at a pre-determined insertion depth thereof.
More particularly, the present invention relates to a device for insertion of deep-in-the-canal hearing aids, that is of hearing aids invisible in the canal that are meant to be worn in the bony region of the ear canal, preferably entirely therein retained, for extended periods, without daily insertion and removal.
Such hearing aids are also generally designated as extended wear hearing aids.
Referring to more specific use cases, the present invention relates to a device designed to allow self-insertion of extended wear hearing aids by the same individual that will be using the hearing aids in an own ear canal; as well as insertion by other operators—not necessarily having the expertise of audiologists—such as caregivers or significant others of such individual user, for instance in a domestic environment.
The present invention also relates to a method of manufacturing an insertion device for inserting, by an operator or by an individual user, a hearing aid deep into an ear canal, at a pre-determined insertion depth thereof.
In the context of the present invention, the term hearing aid shall be understood as a device to be worn directly within the ear of a person to improve the individual hearing capacity of this person. Such an improvement may include preventing reception of certain acoustic signals in terms of ear protection.
Hearing aids normally comprise at least one microphone as electroacoustic input transducer; and at least one speaker—usually called receiver—as electroacoustic output transducer. Generally, hearing aids also comprise an electronic signal processing circuitry, connected with said microphone and said speaker, for the processing and manipulation of electronic signals. This electronic signal processing circuitry may comprise analogue or digital signal processing devices for performing various signal processing functions which may include amplification, background noise reduction, tone control, etc.
As said, extended wear hearing aids are configured to be worn continuously, from several weeks to several months, inside the ear canal, preferably within a reduced, pre-determined distance of the tympanic membrane for optimal functioning. Such devices may be miniature in size in order to fit entirely within the ear canal and are configured such that the speaker, or receiver, fits deeply in the ear canal in proximity to the tympanic membrane of the individual user. Typically, extended wear hearing aids comprise specialized acoustic seals which are configured to suppress sound transmission and feedback and designed to suspend the device comfortably in the limited space offered by the deep ear canal, while maintaining healthy conditions of such ear canal. In the section dedicated to a detailed description of embodiments of the present invention, extended wear hearing aids, to be inserted by devices according to the present invention, will be further introduced in relation to the ear canal characteristics.
Current re-fitting processes of extended wear hearing aids require that patients—otherwise designatable as hearing aid users—visit at least their hearing aid providers. Any adjustment of extended wear hearing aids which implies extraction thereof from an ear canal (including battery replacement) cannot be effectively dealt with by the hearing aid user directly or by unskilled caregivers. According to current practice, only hearing aid providers and skilled operators—such as audiologists, clinicians or similar health care professionals—have the means to evaluate ear health and are qualified to service, refit and program extended wear hearing aids.
The problem of (re-)insertion of extended wear hearing aids arises on occasions when patients may otherwise have to remain without hearing aids for extended periods of time. The unavailability of hearing aids would negatively impact the user experience of a hearing solution which has been originally conceived as a 24/7 hearing solution.
It is recommended in certain circumstances that extended wear aids be removed because their use is not compatible with safety or a correct functioning. For instance, patients that need to go through certain medical procedures, such as MRI, are required to remove their extended wear hearing aids prior to carrying out the examination. Patients that perform certain physical activities, such as swimming or diving, are also recommended to remove their extended wear hearing aids prior to starting their sport session.
For certain elderly or disabled patients visiting their extended wear hearing aid providers for servicing may prove a difficult task, due to physical restrictions and/or to distance and/or accessibility to the provider's office. Patients that travel to locations or countries where there are no extended wear hearing aid providers may not be able to get refitted with a new device, should their devices become non-functional. At any rate, even if one such provider was given at their travel location, it proves often difficult to schedule a refit in a timely manner. In addition, many providers charge a fee for servicing outside patients who are not regular clients.
In light of the above issues encountered when re-fitting according to current practices, tools and procedures effectively enabling self-insertion, or insertion by non-professional operators, of extended wear hearing aids would help reduce trial cancellations, and would let existing customers overcome various difficult situations, while improving overall user experience.
In addition to that, self-insertion may reduce the overall workload of hearing aid providers, as fewer visits would be required per subscription.
Current technology does not allow a controlled, targeted, safe and reliable insertion of extended wear hearing aids in an ear canal. Some patients try to anyhow perform self-insertion of extended wear hearing aids by their own fingers or employing some tool at present available, oftentimes unspecific for this application. This is suboptimal and they would however need at least visual guidance in handling such tools to avoid a risk of injuring themselves.
U.S. Pat. No. 8,155,361 B2 discloses a device for insertion of a hearing aid deep into an ear canal which, to a certain extent, may support insertion by an operator other than an expert health care professional. Such device comprises a capsule, formed by a cover portion and a base portion, wherein the base portion comprises a chimney configured to accommodate and permit passage of a hearing aid. However, the tool therein presented is not perfected in a way that precise placement of the hearing aid in an intended location relative to the ear canal can be attained, at a depth which maximizes the performance of the hearing aid. In fact, from
Moreover, in the case of the insertion tool of U.S. Pat. No. 8,155,361 B2, the deformability of the protruding piston and of the structure supporting it, as well as the design concept of cover, base and chimney according to a “a common one-size-fitting all sizes or most sizes” principle, cannot completely prevent the risk of impacting the walls of the ear canal, in operation. This can be easily derived from the two configurations shown in FIGS. 5 and 6 of U.S. Pat. No. 8,155,361 B2
Thus, there exists a need for a device for insertion of a deep-in-the-canal hearing aid into an ear canal of an individual user which is designed so that:
There also exists a need for a related method of manufacturing an insertion device designed to achieve the abovementioned objectives.
Accordingly, a major objective of the present invention is to provide a new ameliorated design for an insertion device that supports a guided, efficient and accurate placement of an extended wear hearing aid in an intended location within an ear canal at a pre-determined insertion depth thereof; as well as to provide a correlated method of manufacturing such an insertion device.
Another objective of the present invention is to improve the ability of an operator—even one who is not a skilled health professional i.e. not necessarily an audiologist, a clinician or an assistant—to insert an extended wear hearing aid, or similar, in ear canal in a predictable, controlled way. Thus, in order to execute a correct hearing aid placement by using the present invention, there is virtually no need to navigate the insertion through the bodily structures of an ear canal and empirically monitor position and orientation through the insertion process. Thanks to the present insertion device, even the hearing aid user or patient himself can achieve to reach an intended location in the ear canal without assistance by third parties.
Yet other objectives of the present invention are to drastically reduce the risk of injuries, abrasions or hematoma to ear canals when fitting extended wear hearing aids; to improve the success rate in trials to fit such hearing aids; to improve subscription renewal rates to extended wear hearing aid programs; to improve extended wear hearing aid usage convenience; to reduce and rationalise the workload of professional operators such as fitters, eliminating for instance disruptive unscheduled refit procedures.
These problems are solved through an insertion device, and a correlated method of manufacturing such an insertion device, according to the main claims. Dependent claims further introduce particularly advantageous embodiments for such a device and related method.
The inventive solution basically requires to design an insertion device comprising a customized support with a guide channel and with a drive mechanism for moving a hearing aid, through the guide channel, up to a predetermined insertion depth, wherein the customized support comprises an outer profile which is individually shaped to replicate the shapes of at least a portion of a conchal cavity and of an ear canal of an individual hearing aid user. The outer profile is also preferably resistant to deformation.
The design of the insertion device according to the present invention advantageously enables a reliable placement of an extended wear hearing aid within an ear canal which is guided and controlled throughout the insertion process, in that the insertion is compliant with the anatomy of the ear canal.
The design of the insertion device according to the present invention also allows, at least to a certain extent, a de-coupling of the insertion forces applied by an operator on a drive mechanism of the insertion device from the ensuing advancement of the extended wear hearing aid in the ear canal, such that excess forces do not result in an uncontrolled progression of the hearing aid towards a user's tympanic membrane.
In addition to that, the insertion device according to the present invention is especially conceived to pre-arrange the hearing aid, already during the insertion procedure, to suit the lodging region of the ear canal where the hearing aid is meant to be eventually placed. In fact the hearing aid is not only accurately positioned at the correct insertion depth of the ear canal but, preferably, also oriented based on the orientation of the ear canal itself in the lodging region.
Other objectives, features and advantages of the present invention will be now described in greater detail with reference to specific embodiments represented in the attached drawings, wherein:
With reference initially to
In this context, “lateral” will mean oriented or disposed away from the tympanic membrane 56; whereas “medial” will mean oriented or disposed towards the tympanic membrane 56, as also portrayed by way of arrows in
An adult ear canal 50 axially measures, approximately, 25 mm in length from the canal aperture 51 to the tympanic membrane 56. The cartilaginous region 53 is relatively soft due to the underlying cartilaginous tissue, and deforms and moves in response to the mandibular or jaw motions, which occur during talking, yawning, eating, etc. The bony region 54 (also designatable as “bony canal”) is instead rigid, roughly 15 mm long and represents approximately 60% of the canal length. At any rate, canal shape and dimensions can vary significantly among individuals. The skin in the bony region 54 is thin relative to the skin in the cartilaginous region and is typically more sensitive to touch or pressure. There is a characteristic bend which occurs approximately at a junction 55 between cartilaginous region 53 and bony region 54; such bend is commonly referred to as the second bend of the ear.
The ear canal 50 terminates medially with the tympanic membrane 56.
Lateral of, and external to, the ear canal 50 are a concha cavity 60 and a cartilaginous auricle 61. The junction between the concha cavity 61 and cartilaginous region 53 of the ear canal 50 at the aperture 51 is also defined by a characteristic bend 52, which is known as the first bend of the ear canal.
As said, extended wear hearing devices are configured to be worn continuously, from several weeks to several months, inside the ear canal. Some extended wear hearing devices are configured to rest entirely within the bony region 54 and, in some instances, within 4 mm of the tympanic membrane 56. Examples of extended wear hearing devices are disclosed in U.S. Patent Pub. No. 2009/0074220, U.S. Pat. Nos. 7,664,282 and 8,682,016, each of which is incorporated herein by reference.
Referring to Figures from 2 to 4, an exemplary extended wear hearing device 200 comprises a core 202; a medial and a lateral seal retainer (or “seals”) 204 and 206, and a removal loop 208. Typically, a contamination guard with a screen (not shown) abuts a microphone. The core 202 usually includes a housing as well as a battery, a microphone, a receiver, and control circuity located within the housing. The seals 204 and 206 suspend and retain the hearing device core 202 within the ear canal 50 and also suppress sound transmission and feedback which can occur when there is acoustic leakage between the receiver and microphone.
The seals 204 and 206 are frequently formed from a highly porous and highly compliant foam material (e.g., hydrophilic polyurethane foam), which conforms to the ear canal geometry by deflection and compression, as it is illustrated in
It is especially important that the seals be properly sized for the intended ear canal and that the interface between ear canal 50 and seals 204, 206 be even, without irregularities such as gaps or folds, in order to prevent discomfort and inadequate feedback suppression.
Attaining, upon insertion, an optimal insertion depth d (as measured, for instance, from the canal aperture 51) of a hearing aid 200 inside the ear canal 50 is of paramount importance in order to prevent any discomfort in use of the hearing aid, as well as any injury during and at completion of the insertion procedure; and in order to maximize the beneficial effects of the hearing aid on the sound and noise perception of a hearing aid user.
Also, it is important to prevent situations as shown in
In the present invention, an insertion device 100 for insertion of a deep-in-the-canal hearing aid 200 into the ear canal 50 of an individual user at a pre-determined insertion depth d comprises a customized support 1 and a drive mechanism. The drive mechanism is preferably actuatable by the individual user himself, in case of self-insertion in an own ear canal, or by a distinct insertion device operator. By the wording “individual user” in the following, the individual hearing aid user will be generally meant.
With reference to
The drive mechanism is configured to move the hearing aid 200 through the guide channel 3, from the lateral entry opening 4, through the medial exit opening 5, up to a pre-determined insertion depth d.
The outer profile 2 is individually shaped to replicate the shapes of at least a portion of the conchal cavity 60 and of the ear canal 50 of the individual user. The outer profile 2 is also resistant to deformation.
In fact, the outer profile 2 is preferably substantially undeformable, in that it does not give way under an applied pressure to the extent of changing its shape.
In a preferred embodiment, the outer profile 2 is rigid. Thus, preferably, from the phase when the customized support 1 is snugly fitted to the conchal cavity 60 and to the ear canal 50; to the phase when the hearing aid 100 is let out through a medial exit opening 5 and deployed in the ear canal, the outer profile 2 keeps its shape originally conforming to the anatomy of the concha and of the ear canal.
Therefore, preferably throughout the guided passage of the hearing aid 200 from the lateral entry opening 4 to the medial entry opening 5, during activation of the drive mechanism, the outer profile 2 keeps its original shape.
The guide channel 3 is also, preferably, individually configured to direct the passage of the hearing aid 200 therethrough, from the lateral entry opening 4 to the medial exit opening 5, such that the hearing aid is let out, by the medial exit opening 5, at a pre-determined insertion depth d in the ear canal. With reference to
In particular cases, the medial exit opening 5 can be directly located at pre-determined insertion depth d, the distance Δ being 0.
Preferably, the guide channel 3 at the medial exit opening 5 is oriented based on an orientation of the lodging region LR of the ear canal 50 of the individual user. Such lodging region LR is located beyond—or medial of—the medial exit opening 5 and is intended to accommodate the hearing aid 200. By adopting such a configuration of the guide channel 3, it can be advantageously ensured that the hearing aid 200 is pre-arranged to conform to the anatomy of the ear canal 50 at the destination location where it is meant to be eventually placed. Therefore, the hearing aid 200 is moved to the intended lodging region LR, and will sit therein, smoothly and compliantly, in a way that suits the local ear canal anatomy.
Alternatively, for special cases in which the anatomy of the ear canal 50 keeps a rather consistent shape in the bony region 54—for instance, when the orientation does not substantially change between the level where the medial exit opening 5 will be and across the intended lodging region LR—the guide channel 3 at the medial exit opening 5 can be oriented based on an orientation of the ear canal 50 at the pre-determined insertion depth d or at an end plane E of the insertion device 100 where the medial exit opening 5 lies.
With reference to
Both in
In such a case, the central axis A-A of the guide channel 3 at the medial exit opening 5 defines an elevation angle β, with respect to the device end plane E different from 90° and the projection of the central axis A-A on the device end plane E defines an azimuthal angle α different from zero. As the hearing aid 200 is pushed through the guide channel 3, it will automatically align itself with the axis A-A and will exit along a vector a, according to the medial end of the guide channel 3 (in this case, not according to the medial end of the outer profile 2 of the customized support 1).
In special cases of ear canal geometries, it may be instead verified that the normal n to the device end plane E and the central axis A-A of the guide channel 3 at the medial exit opening 5 are aligned.
With reference to
An orientation of the medial exit opening 5 of the guide channel 3, with respect to the shape of the cross-section of the customized support 1 lying on the device end plane E, can be therefore complemented with the information of the angle θ comprised between a major axis M-M of the guide channel 3 and a major axis CE-CE of the customized support 1 (or of the ear canal 50) on such device end plane E.
With reference to
The present invention proposes of designing a major axis M-M of the medial exit opening 5, oriented as indicated by a unitary vector m, aligned with the major axis CLR-CLR of a first elliptical cross section of the ear canal 50, positioned beyond—or medial of—the device end plane E and in the lodging region LR intended to ultimately accommodate the hearing aid 200. By adopting the above design conditions, it can be guaranteed that, when ejected, the hearing aid 200 will be not only placed at the right insertion depth d, but will be correctly oriented in the ear canal 50, also in terms of rotation angle θ about the normal to the device end plane E.
Even though the individual ear canal 50 in one or more locations is not elliptical in cross-section, it is still important to control the rotation angle θ imparted to the hearing aid 200 at its exit from the insertion tool 100. For instance, if the ear canal 50 is roughly circular or irregularly cylindrical in cross section at the medial exit opening 5 of the insertion device 100, but becomes predominantly elliptical in cross section beyond—or medial of—such opening 5 in the lodging region LR, then it is still critical that locally, i.e. at the end plane E, the major axis M-M of the guide channel 3 line up with the major axis of the ear canal at the lodging region LR. In short, the guide channel 3 at the end plane E shall reflect the orientation of the ear canal 50 where the hearing aid 200 will ultimately be lodged.
In the context of the present invention, it is important, for placement of a hearing aid 200 deep within the ear canal 50 that is both comfortable and free from acoustic feedback, to control the abovementioned degrees of freedom d, α, β, and/or θ during the insertion process. Such control is primarily achieved by the specific design of the guide channel 3 as described. The control can also be further influenced by factors such as insertion speed imparted by the driving mechanism and by insertion techniques such as forward motion periodically interspersed with retrograde motion.
With reference to a possible embodiment as represented in
With reference, instead, to another possible embodiment as represented in
On another aspect of the design of the guide channel 3, in
With reference to both embodiments of the insertion device 100 according to the present invention, respectively represented in
At least a component 6, 7, 8 of the drive mechanism can be made of a flexible material and/or at least inner walls of the guide channel 3 can be made of compliant material, so that maneuvering the hearing aid 200 through the twists of the ear canal 50—and of the guide channel 3—is made easier and several kinds of movements can be accommodated.
With reference to the first embodiment of the insertion device of
In the particular case portrayed in the above Figures, the first drive member 6 advances with a linear movement.
Preferably, the first drive member is a screw rod 6 and the second rotating driving member is a knob or wheel 7 threadedly engaging the screw rod 6.
The screw rod 6 is formed with at least a helical thread, preferably with two threads. The use of two, or more, adjacent but independent threads, for instance helical threads, has the advantage of offering a relatively large contact area between screw rod 6 and knob 7, while preserving the flexibility properties of the screw rod 6 and also allowing a fast insertion with a relatively low number of knob revolutions.
In fact, a substantial contact area between drive mechanism components is important to guarantee that a high torque moment applied to the knob 7 by a user does not result in excessive stresses damaging the screw rod thread.
A thread pitch p of the screw rod 6 comprised in a range of 3-5 millimeters, preferably combined with a double helix, may be optimal in balancing the need of enough flexibility and robustness of the mechanism and the desire to keep the revolutions for carrying out insertion of the hearing aid to a relatively low number.
By way of example, a thread angle of around 4° and a thread thickness comprised in a range of 0.5-1 mm may prove advantageous for bendability and compliance in the guide channel 3, on one hand, and robustness, on the other hand.
It is possible according to the present invention, though not an absolute requirement, to differentiate a device 100 intended for hearing aid insertion in a right ear from a device 100 intended for hearing aid insertion in a left ear, in that the former can be provided with right-handed threads, whereas the latter can be provided with left-handed threads. By doing so, an operator or a user will be able to manipulate the insertion device 100 intuitively, always turning the knob 7 forward or clockwise for either ear, by applying a rotation oriented towards the user's own nose. The insertion technique will thus be easier to remember and master than in the case where the insertion device according to the present invention needs to be turned forward or clockwise for insertion on one side, but backward or anti-clockwise for insertion on the opposite side.
Preferably, the screw rod 6 and/or the knob or wheel 7 and/or the inner walls of the guide channel 3 are made of, or coated with, lubricious material, such as Teflon, for improved slidability of the drive mechanism relative to the guide channel 3. It may also be possible to actively lubricate screw 6 and/or knob 7 and/or inner walls of the guide channel 3.
Preferably, the screw rod 6 has an elliptical cross section to key to the elliptical cross section of said guide channel 3. Thus, the screw rod 6 is prevented from spinning in place as the knob 7 is turned and from not progressing either forwards or backwards.
As shown in
The arrangement is such that free rotative movement of the second drive member 7 is allowed relative to the faceplate 9. The faceplate 9 comprises a through bore 10 configured so that the first drive member 6, displaced by the second, rotating drive member 7, enters the guide channel 3 through the lateral entry opening 4, thus moving the formerly loaded hearing aid 200, through the guide channel 3, to the pre-determined insertion depth d.
The faceplate 9 and the customized support 1 comprise a loading mechanism, arranged such that, in an insertion configuration such as the one shown in
In a loading configuration, such as the one shown in
The loading mechanism may comprise a hinge 12 by which the faceplate 9 is rotatively engaged with the customized support 1.
The first drive member 6 preferably comprises a stop element 13 configured to abut against a lateral stop surface 14 of the second drive member 7, so as to define the maximum advancement possible of said first drive member 6 in the guide channel 3.
The length of the first drive member 6 is such that, when totally inserted, a medial end thereof protrudes out of, or is substantially flush with, the medial exit opening 5, so as to bring the hearing aid 200 to the pre-determined insertion depth d in the ear canal 50.
In a further embodiment of the present invention (not shown), the drive mechanism above described could be modified in the sense of eliminating the interface of the knob 7 and modifying the faceplate 9 to threadedly engage the screw rod 6. The faceplate would incorporate a female thread engaging means, matching with the screw rod's thread. In this case, the screw rod 6 would be directly rotated by the operator or user, advancing in this case with both a linear and a rotational movement through the guide channel 3.
With reference to
In the specific example of
Preferably, the length 1 and/or the radius r of the lever push rod 8 is a function of the anatomy of the ear canal 50 of the individual user.
An insertion device 100 according to the present invention as represented in
Preferably, at least a drive member 6,8 of the drive mechanism comprises a medial pad element 15 adapted to contact the hearing aid 200 when moving through the guide channel 3. Such a medial pad element 15 can comprise a concave recess adapted to receive the hearing aid 200 and may be therein cushioned so as to not damage in any way the lateral end of the hearing aid 200 and for protection of the ear canal walls. The medial pad element 15 may also comprise frictional surface patterns or features, so as to have a better grip on the hearing aid 200. The medial pad element 15 may be attached to said drive member 6, 8 by a rotatable joint, such as a ball and socket joint, so that the movement of the hearing aid 200 along the guide channel 3 can benefit from more degrees of freedom and rotational adjustments are made easier.
Moreover, the drive mechanism—for instance, drive members 7 or 8- and/or the medial pad element 15 can also comprise a damping feature for applying a damping coefficient, such as a dashpot or similar, so that the insertion happens even more smoothly and brisk operator or user movements are even further decoupled from the advancement imparted to the hearing aid 200.
With reference to
An insertion device 100 according to the present invention can also comprise an electroacoustic detection means and/or a visual detection means (in either case referenced in the drawings by number 18) for detecting and verifying the functionality of the hearing aid 200 and/or for enabling an evaluation of an individual user of such hearing aid 200. The electroacoustic detection means can, for instance, take the form of a microphone and/or a receiver. The evaluation of the individual user can therefore be an audiological evaluation. A camera can be employed as the visual detection means. Therefore, an audio and/or visual alert system is enabled, for instance to signal unsuccessful hearing aid insertion; or lack of proper acoustic output in the hearing aid; or detection of critical feedback levels. Follow-up actions can be instructed from remote, as a result of the above alerts, according to a pre-programmed workflow, for instance by way of re-programming, adjusting gain levels or instructing to insert an extended wear hearing aid anew or replace it.
An insertion device 100 according to the present invention may comprise humidity sensor means 19 for measuring the humidity in an ear canal 50 and/or optical measurement means for detecting the physical state of said ear canal 50. Thus, ear health data can be collected to monitor the level of humidity in an ear canal 50. Moisture accumulation was in fact found to lead to early hearing aid failures. A connected mobile platform as above introduced, cooperating with the insertion device 100 according to the present invention, can be provided with an algorithm to determine a current status of ear health. The related information can then be forwarded to a health care professional or to a customer service of the hearing aid manufacturer. In critical cases, based on the indications coming from the insertion device 100, it can be recommended that a patient seek medical evaluation, therefore reducing the risk of injury in case of hearing aid self-insertion.
An insertion device 100 according to the present invention may also be provided with presence and/or proximity sensor means 20 and/or visual detection means 20 for detecting the presence of a foreign object 500 or of a pre-existent hearing device in the ear canal 50. Preferably, such presence and/or proximity sensor means and/or visual detection means cooperates with locking means 16 for locking the drive mechanism 6, 7 moving said hearing aid 200 through the guide channel 3. Such presence and/or proximity sensor means 20 may also comprise or cooperate with alert means to signal the presence of a foreign object 500 or of a pre-existent hearing device, for instance to the individual user or to an operator, by producing audio alert signals and/or visual alert signals.
The insertion device 100 according to the present invention can be advantageously used for achieving an accurate, effective and customized placement into an ear canal also of other devices, different from an extended wear hearing aid 200.
By way of example, the insertion device 100 can be employed for guiding the placement of a multi-functional communication unit into an ear canal 50, at a pre-determined insertion depth d thereof, by an operator distinct from an individual user receiving the multi-function communication unit, or directly by the individual user.
Said communication unit can be configured to detect and transfer to further entities, located external to the ear canal 50, information relating to the ear canal itself and/or relating to a hearing aid 200 already in place deep in such ear canal 50. For instance, the multi-function communication unit could cooperate with a mobile platform, similarly to what above introduced in connection with data collection by the insertion device 100. By providing said multi-functional communication unit with control means and sensing means as described in combination with the insertion device 100, data relating to the state of an ear canal and/or relating to a hearing aid 200 can be forwarded to a customer service or to a health care professional, also after completion of the insertion of a hearing aid 200 by an insertion device 100. Troubleshooting of detected critical situations or evaluation of patient's health and hearing is thereby enabled. A multi-functional communication unit can be left in the ear canal 50 for the time required to collect and transmit the necessary data, and subsequently retracted by using the same insertion device 100 used for the placement thereof.
The present invention also relates to a method of manufacturing an insertion device 100 for inserting a hearing aid 200 deep into an ear canal 50, at a pre-determined insertion depth d thereof. As pointed out, an insertion device operator can be directly the individual user of the hearing aid, self-manipulating the insertion device in an own ear canal; or a distinct operator assisting the individual hearing aid user.
Such method comprises the steps of obtaining data representative of shape and orientation of at least a portion of a conchal cavity 60 and of an ear canal 50 of a hearing aid user. The concept of orientation in an insertion device 100, in relation to an ear canal 50, has been introduced above when describing
The method comprises further the steps of providing, based on said shape and orientation data, a customized support 1 as above described, comprising:
The drive mechanism is preferably provided with at least one rotating drive member (such as knob 7 or lever push rod 8) configured such that, during activation of the drive mechanism through rotation of the rotating driving member, an advancement of the hearing aid 200 through the guide channel 3 is at least partially decoupled from the force applied by the insertion device operator on such at least one rotating drive member 7; 8.
The guide channel 3 is designed by taking into account the orientation α, β, θ of a lodging region LR of the ear canal 50 of said individual user, beyond the medial exit opening 5, intended to accommodate the hearing aid 200. In particular cases—especially when the ear canal 50 substantially keeps one same conformation over a longer trait—the orientation α, β, θ of the ear canal 50 at the pre-determined insertion depth d and/or at the insertion device end plane E can be taken into account for designing the guide channel 3.
The method according to the present invention can comprise the step of providing the guide channel 3 with a substantially elliptical cross section, at least at said medial exit opening 5, and the step of aligning a major axis M-M of said substantially elliptical cross section with a major axis CLR-CLR of a first elliptical cross section of the lodging region LR of the ear canal 50.
Alternatively—especially for cases of an ear canal 50 that remains unchanged over a longer portion of its longitudinal axis—the major axis M-M of such substantially elliptical cross section can be aligned with a major axis C-C of a second elliptical cross section of the ear canal 50, for instance at said pre-determined insertion depth d and/or at the insertion device end plane E (in this latter case, for example, the distance Δ shown in
Furthermore, the method according to the present invention may comprise the step of determining the orientation of the lodging region LR based on the orientation of a multiplicity of cross sections of the ear canal 50. This may be achieved, for instance, by making an average of the orientation of intermediate cross-sections of the ear canal 50 disposed across the lodging region LR where the hearing aid 200 is intended to be accommodated. Such a multiplicity of cross sections may be chosen among orthogonal cross-section which are perpendicular to the longitudinal axis of the ear canal 50. The average above defined can be a weighted average of the orientation of intermediate cross-sections of the ear canal 50.
Providing a guide channel 3 internal to the customized support 1 as above described preferably comprises the step of taking into account the constraint of the outside profile 2 of the customized support 1.
The shape and orientation data of at least a portion of a conchal cavity 60 and of the ear canal 50 are preferably derived by:
The information necessary in order to design the outer profile 2 and the guide channel 3 of the customized support 1 can be collected by scanning an impression 400 as shown in
The impression 400 comprises a cured impression-taking material and an impression-taking pad 300 fixedly engaged with the cured impression-taking material. The contour of the impression substantially provides the information relative to the outer profile 2 of the customized support 1 of the present insertion device 100.
The impression 400 is obtained by inserting the impression-taking pad 300 in the ear canal 50 by some currently available tool in a way that a medial end of the impression-taking pad 300 is arranged in the ear canal 50 proximate to a tympanic membrane 56. Subsequently, the ear canal 50 and at least part of the concha 60 is filled with impression-taking material, for instance a silicone based material, up to the impression-taking pad 300, which remains embedded into the impression-taking material. The impression-taking material is let cure within the ear canal 50 to become integral with the impression-taking pad 300 and to consequently form the impression 400.
In
The scanning of the impression 400 results in precise ear canal impression model data, complete with the information conveyed by the impression pad 300. Such data can be further refined or processed by some CAD design software.
Consequently, the customized support 1 can be manufactured—preferably by means of a subtractive (e.g. milling) and/or additive (e.g. rapid prototyping) production step(s)—using such ear canal impression model data. This allows to obtain a high quality customized support 1 of an insertion device 100 according to the present invention. Post-processing may be desired, for instance in order to eliminate undercuts from the outer profile 2 and improve the ability of the insertion device 100 to slide in the ear canal 50, by expressly creating additional margins of tolerance in selected areas.
In order to further improve the precision of the design of the customized support 1 of the insertion device 100 according to the present invention, a sizer replicating the geometry of the hearing aid 200 can be used as impression-pad 300 in the above described impression-taking procedure. The word “sizer”, in the present context, designates a device having substantially the same medial and lateral seal retainers (or “seals”) 204 and 206 as the hearing aid 200 to be inserted; and a non-operative core dimensionally equivalent to the core of such hearing device 200. For this purpose, also a two-part sizer can be used as described in PCT/US2016/021845, which is hereby incorporated by reference. In this latter case, a lateral portion of the sizer (equivalent to the lateral seal retainer 206) can be removed, once the complete sizer has been introduced in the ear canal at a pre-determined location substantially corresponding to the pre-determined insertion depth d. The medial portion of the sizer (equivalent to the medial seal retainer 204) is left behind in the ear canal 50. Impression material will be then injected in the ear canal and will cure, binding with the medial portion of the two-part sizer.
Thus, scanning of an ear mold impression 400 retaining such a sizer in-situ will provide not only reliable information on the configuration of the deep ear canal, but also information on the actual placement of the hearing aid 200 relative to the ear canal 50 which is extremely consistent with the intended scenario.
In order to manufacture the insertion device 100 according to the present invention, it may also be envisaged a simplified procedure to be carried out totally in-situ. In this instance, a dummy insertion device already incorporating a preliminary guide channel may be provided, to be further customized in situ during impression taking operations. After inserting the guide channel in the bony region of the ear canal 50, impression taking material is employed to fill the ear canal and at least part of the concha and to therein cure. As a result of curing, the actual anatomical situation is “frozen” in situ and a possible configuration of the customized support 1 and of the guide channel 3 is directly obtained. In this simplified case, no scanning of the impression 400 is needed, as the impression-taking procedure itself, in cooperation with a dummy insertion device, produces a customized insertion device, to be possibly further complimented with a drive mechanism and/or other components.
Conversely, once the insertion device 100 according to the present invention has been manufactured, it can be advantageously used also to guide and assist with a precision placement, in an individual ear canal 50, of oto-dams or sizers, alleviating the difficulty that hearing aid fitters encounter when performing these tasks.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2016/038179 | 6/17/2016 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2017/218012 | 12/21/2017 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 4756312 | Epley | Jul 1988 | A |
| 8155361 | Schindler | Apr 2012 | B2 |
| 8184842 | Howard | May 2012 | B2 |
| 8411889 | Naumann et al. | Apr 2013 | B2 |
| 9936314 | Rasmussen | Apr 2018 | B2 |
| 20080144871 | Purcell | Jun 2008 | A1 |
| 20110188692 | Naumann | Aug 2011 | A1 |
| 20130223666 | Michel | Aug 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 2922312 | Sep 2015 | EP |
| Entry |
|---|
| International Search Report and Written Opinion; Application Nr. PCT/US2016/038179 filed on Jun. 17. 2016; dated Feb. 16, 2017; 11 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20190230453 A1 | Jul 2019 | US |
