Patent Application
20080273733
A wide variety of hearing aid instruments are known in the art. Most hearing aids, worn in the ear (ITE) or behind the ear (BTE) occlude to some degree the ear canal, causing an occlusion loss. Occlusion loss is described as a difference between performance of an open ear response (REUR—real ear unaided response) and the performance of an ear with a hearing aid in place but turned off (REAR—real ear aided response with hearing aid turned off). Therefore, placing a hearing aid in the ear eliminates the natural ability of the patient's concha and the ear canal to produce a resonance between, e.g., 2000 and 4000 Hz (hertz), which naturally increases sounds entering the ear. This important feature allows human ear to better understand speech information. The average enhancement is about 16 to 20 dB. It can be clearly seen that a loss of 16 to 20 dB (loss of REUR) in addition to a loss due to a mechanical structure of the hearing aid can create a significant occlusion loss of sometimes up to 40 dB at frequencies between 2000 and 4000 Hz. This presently described hearing aid is configured to eliminate and/or significantly reduce such loss (terms “occlusion loss” and “insertion loss” when a hearing aid is inserted into an ear but turned off are used interchangeably).
Also, most hearing aids—either ITE or BTE—positioned within the ear canal create an occlusion effect. That is, the occlusion effect is associated with the sensation or feeling that the patient's head is “at the bottom of the barrel,” with the patient's own voice becoming intolerably loud. This is often related to a patient's rejection of the amplification due to the patient's discomfort with the patient's own voice.
Placing an earmold or a shell of a custom made hearing aid within the ear canal can produce a low frequency amplification of the patient's voice of between about 10 and 20 decibels. This can relate to a perceived loudness increase in the patient's own voice of about four times the actual loudness of the patient's voice.
Accordingly, there remains a need in the art for a hearing aid that avoids the occlusion loss and occlusion effect problems described above.
The above-discussed and other drawbacks and deficiencies of the prior art are overcome or alleviated by the presently described hearing aid system, including a receiver unit configured and positioned within the user's ear canal so as to minimize insertion loss and/or occlusion effect. This new and unique positioning of a speaker (or receiver or receiver unit as used herein, which receiver unit need not necessarily include, e.g., additional electronic, amplification, processing, etc. aspects apart from the speaker itself) also provides improved characteristics of sound delivery into a hearing impaired ear.
In another embodiment, such receiver unit creates an insertion loss over the audible range of human hearing below about eight decibels.
In another embodiment, a micro-receiver unit is positioned in an open-ear configuration within the ear canal of a user, and a sound processing unit positioned behind the pinna is linked to the micro-receiver unit. The described hearing aid advantageously reduces the insertion loss and occlusion effect.
In one exemplary embodiment, the receiver unit has a maximum lateral dimension Ø. Such dimension describes the maximum overall dimension or diameter (though it is not to be implied that the cross section of the receiver unit must be circular or oval or any other geometric shape) of the receiver unit. In one exemplary embodiment, the receiver unit has a dimension Ø that is less than the maximum lateral dimension or diameter of the user's ear canal. In another embodiment, the receiver unit has a dimension Ø that is less than half the maximum lateral dimension or diameter of the user's ear canal. In another embodiment, the receiver unit has a dimension Ø that is less than twenty percent of the maximum lateral dimension or diameter of the user's ear canal. In another embodiment, the receiver unit has a dimension Ø that is less than ten percent of the maximum lateral dimension or diameter of the user's ear canal. In another embodiment, the receiver unit has a dimension Ø that is less than five percent of the maximum lateral dimension or diameter of the user's ear canal.
In another exemplary embodiment, the hearing aid comprises a sound processing unit, a receiver unit, and an intermediate connecting portion between the sound processing unit and the receiver unit, wherein the intermediate connecting portion comprises an electrical conducting component and a stiffening wire, provided on at least a portion of the intermediate connecting portion. The stiffening wire may comprise any material that provides stiffness to the intermediate connecting portion, e.g., metal, plastic or the like. Additionally, the conducting wire may also serve as the stiffening wire. In an exemplary embodiment, the stiffening wire comprises a stainless steel wire. In another exemplary embodiment, the stiffening wire comprises a metal or alloy of metals having memory such that the wire may deflect and return to an original orientation. Such may be stainless steel, among others. Such may also be a shape memory alloy.
In another exemplary embodiment, the stiffening wire is provided within or on a portion of the intermediate connecting portion and extends within or on at least a portion of the receiver unit. In such embodiment, the receiver unit is positioned on the intermediate connecting portion with greater stability and resiliency. Also where a stiffening element is used, the intermediate connecting portion and receiver unit may be custom manufactured or custom molded to optimize positioning of the receiver unit within the ear canal and/or to optimize positioning of the intermediate connecting portion.
In another embodiment, a retaining wire extends from one of the stiffening wire and the receiver unit. The retaining wire is configured to position within a portion of the concha of the ear. In such embodiment, the retaining wire may be configured to prevent excessive insertion of the hearing aid receiver unit into the ear canal. Also, the retaining wire may be configured to cause the hearing aid receiver unit to be suspended within a portion of the ear canal, such that no portion of the receiver unit touches the sides of the ear canal.
In another embodiment, the electrical conducting component comprises two wires within distinct channels or otherwise isolated from one another within the intermediate connecting portion. In another embodiment, a stiffening element is provided within or on the intermediate connecting portion within a distinct channel or otherwise isolated from the wires.
In another embodiment, the receiver unit comprises a speaker, at least partially enclosed within a casing having first and second end portions, the first end portion communicating with the intermediate connecting portion, the speaker communicating with a port provided at the second end portion of the casing. In another embodiment, the casing is sealed to fluids at the first end portion and along a length of the casing extending from the first end portion to the port provided at the second end portion. The port may also be sealed to fluids by a membrane or mesh material.
The above-discussed and other features and advantages of the present invention will be appreciated and understood by those skilled in the art from the following detailed description and drawings.
Referring now to the exemplary drawings wherein like elements are numbered alike in the several FIGURES:
Referring now to
Referring now to
Referring again to
While stiffening of the intermediate connecting portion 20 is described above with regard to a stiffening wire, it is to be recognized that alternate stiffening mechanisms are contemplated. For example, any material of the intermediate connecting portion 20 may comprise a stiff material, including the material of the conductor. Additionally, the stiffening wire may comprise any material that provides stiffness to the intermediate connecting portion, e.g., metal, plastic or the like. Such material may have memory properties or not. In one exemplary embodiment, an outer tube 39 of the intermediate connecting portion comprises a stiff material. In one exemplary embodiment, tube 39 comprises a stainless steel wire. In another exemplary embodiment, the tube 39 comprises a metal or alloy of metals having memory such that the wire may deflect and return to an original orientation. For example, the tube 39 may be a shape memory alloy.
Referring now to
Referring now to
Referring to
Referring now to
Referring now to
Referring now to
Also as illustrated by
In the exemplary embodiments described by
Referring now to
While material of the supported surface 88 should be rigid enough to retain some supported configuration, it is contemplated, in one embodiment, that such supported surface 88 be able to bend around contours of the ear canal. Supported surface 88 and support 90 may comprise the same material or have the same properties (resilience, thickness, etc.), or they may comprise different materials or have different properties. Additionally, where the material properties of the supported surface 88 and/or support 90 do not tend to hold position when the actuation portion 94 is adjusted along direction lines A or B, the actuation portion 94 may be configured to frictionally engage, hold or lock against the intermediate connecting portion 20.
Referring again to
With reference to
Referring again to
Referring again to
Referring now to
Referring now to
The following TABLES summarize the data collected by analysis of the presently disclosed open ear hearing device (V=Vivatone) along with three additional hearing devices (G=General Hearing Instruments (GHI), O=Oticon, and S=Sebotek) on twelve subjects (Group A).
For purposes of Group A testing, the Vivatone Device was configured in an open ear configuration with a receiver unit size of 0.149 inches (in). It is to be recognized that while the tested Group A Vivatone receiver unit had a maximum lateral dimension of 0.149 in, any receiver unit size facilitating an open ear configuration is contemplated (as discussed in the above Summary and above within the Detailed Description).
The tested General Hearing Instruments was a canal-open-ear (COE) Auris™ hearing aid. The tested Oticon Device was a low profile, Open Ear Acoustics™ configuration per Oticon. The tested Sebotek Device was the PAC (Post Auricular Canal) hearing aid also described by U.S. Pat. No. 5,606,621 to Reiter, the entire contents of which are specifically incorporated herein by reference.
An additional twelve subjects (Group B) participated in an evaluation of six Vivatone hearing devices with different size receiver unit modules (None (nothing in the ear), V=0.149 in, 1=0.170 in, 2=0.190 in, 3=0.210 in, 4=0.230 in).
The analyzed data includes the measurements from the Probe Real Ear Insertion Response Curve, which consisted of differences between the Probe Real Ear Unaided Response Curve (for measurements of insertion loss) and the Probe Real Ear Aided Response Curve and the corresponding values repeated while the subject vocalized the letter “EE” (for measurement of occlusion effect). We call the first two differences the Insertion Response (or insertion loss) and the last two differences the Occlusion Effect. Values are given at 79 frequencies (200 Hz to 8000 Hz at increments of 100 Hz).
Analysis of variance models were run for each frequency. Comparisons are adjusted for Subject variability and Order of Test. Repeated observations for each subject were not included in the analysis of variance since the variability from the repeated tests was quite small. All calculations were carried using the R software package.
Comparison results are given in the below TABLES 1-12. Results are given for each frequency. TABLE 1 provides estimates and standard errors of the Insertion Response for the evaluated hearing devices tested with Group A. TABLE 2 provides comparisons of each non-Vivatone Group A device to the Vivatone device. Positive values indicate that the Insertion Loss was greater for the non-Vivatone device. Negative values indicate that the Insertion Loss was greater for the Vivatone device. Simply stated, the smaller the Insertion Loss, the least effect inserting a hearing aid has on changing the natural characteristics of the ear. For example, an insertion loss of −8 dB means that the ear lost 8 dB of sounds in comparison to an unaided ear. T-values equal to or greater than 2.47 are statistically significant (adjusting for multiple comparisons). TABLES 1-2 follow:
TABLE 3 provides estimates and standard errors of the Occlusion Effect for hearing devices evaluated by Group A. Increased positive values at frequencies between 200 Hz and 1000 Hz (the low frequency human hearing range sounds are mainly responsible in providing an occlusion effect) indicate greater occlusion effect. For example, a 10 dB value indicates the existence of a very significant occlusion effect. TABLE 4 provides comparisons of each non-Vivatone Group A device to the Vivatone device. Positive values indicate that the Occlusion Effect was greater for the non-Vivatone device. Negative values indicate that the Occlusion Effect was greater for the Vivatone device. T-values equal to or greater than 2.47 are statistically significant (adjusting for multiple comparisons). TABLES 3-4 follow:
TABLE 5 provides estimates and standard errors of the Insertion Response for hearing devices evaluated by Group B. TABLE 6 provides comparisons of each Vivatone Group B device condition to the None condition (that is, no receiver unit in the ear). Positive values indicate that the Insertion Response was greater for the Vivatone device condition. Negative values indicate that the Insertion Response was greater for the None condition. T-values equal to or greater than 2.59 are statistically significant (adjusting for multiple comparisons). TABLES 5-6 follow:
TABLE 7 provides estimates and standard errors of the Occlusion Effect for hearing devices evaluated by Group B. TABLE 8 provides comparisons of each Vivatone Group B device condition to the None condition. Positive values indicate that the Occlusion Effect was greater for the Vivatone device condition. Negative values indicate that the Occlusion Effect was greater for the None condition. T-values equal to or greater than 2.59 are statistically significant (adjusting for multiple comparisons). TABLES 7-8 follow:
TABLE 9 provides estimates and standard errors of the Perceived Occlusion Effect for hearing devices evaluated by Group A. TABLE 9 also provides comparisons of each non-Vivatone Group A device to the Vivatone device. Positive values indicate that the Perceived Occlusion Effect was greater for the non-Vivatone device. T-values equal to or greater than 2.47 are statistically significant (adjusting for multiple comparisons). TABLE 9 follows:
TABLE 10 provides estimates and standard errors of the Perceived Occlusion Effect for hearing devices evaluated by Group B. TABLE 10 also provides comparisons of each Vivatone Group B device condition to the None condition. Positive values indicate that the Perceived Occlusion Effect was greater for the Vivatone device condition. T-values equal to or greater than 2.59 are statistically significant (adjusting for multiple comparisons). TABLE 10 follows:
TABLE 11 provides estimates of the correlation between the Occlusion Effect and the Perceived Occlusion Effect for Group A. The correlation is computed after adjusting for subject effects. A separate correlation is computed for the Occlusion Effect at each measured frequency and the Perceived Occlusion Effect. P-values are given for each correlation value to assess statistical significance. TABLE 11 follows:
TABLE 12 provides estimates of the correlation between the Occlusion Effect and the Perceived Occlusion Effect for Group B. The correlation is computed after adjusting for subject effects. A separate correlation is computed for the Occlusion Effect at each measured frequency and the Perceived Occlusion Effect. P-values are given for each correlation value to assess statistical significance. TABLE 12 follows:
With reference to TABLE 1, the following interpretive summary of data across the tested frequencies might apply with regard to loss of the natural resonance of the ear (frequencies largely between 1500 Hz and 5000 Hz; see Shaw EAG. Transformation of sound pressure from the free field to the eardrum in the horizontal plane. Journal of the Acoustical Society of America 56: 1848-1861, 1974.) due to insertion loss: GHI has about −9 to −10 dB of insertion loss; Oticon has about −20 dB of insertion loss; Sebotek has about −20 to −29 dB of insertion loss; and Vivatone has about −0 to −2 dB of insertion loss (standard error is about 0.75).
Thus, it is evident from the data of TABLE 1 that positioning a Vivatone hearing aid into the ear changes the natural hearing (REUR) almost none. The numbers for the Vivatone are near 0 (zero) from 200-2600 Hz and approximate 2 dB in the higher frequencies. It is likely that from a clinical point of view, a Vivatone hearing aid user would not notice a 2 dB change. If such is the case, then the data shows that the Vivatone device does not make an appreciable change in open ear hearing and is, therefore, transparent to the sounds entering an ear canal. In contrast, all the other tested hearing aids make substantial reductions (It should be noted that if a user is presented a high frequency sound like “tch, tch, tch” at a moderate level, and if only a 6 dB change in intensity is made, the user will easily notice the changes, since a 6 dB change in intensity results in doubling loudness perception from a psychoacoustics point of view.
According to the data in TABLE 1, the least occlusion loss (outside of Vivatone) was present with the GHI device, which causes a loss in the 9-10 dB range in the high frequencies. The Oticon instrument was responsible for as much as a 20 dB change and the Seboteck instrument resulted in a 20-29 dB change. For example, a change of 20-30 dB in high frequency is so substantial that inserting fingers into ears and blocking off the ear canals produces a decrease in the high frequencies of about 30 dB. A 30 dB change produces a 10-fold change in loudness from the loudness perception point of view.
With reference to TABLE 3, the following interpretive summary of data across the most relevant frequencies (about 200 Hz to about 1000 Hz) might apply with regard to the Occlusion Effect (that is, change in the sound pressure level of the voiced sound “ee” resultant from inserting a hearing aid into the ear, measured in the ear canal between a turned-off hearing aid and the eardrum: GHI has about +8 to 10 dB of Occlusion Effect; Oticon has about +12 to 16 dB of Occlusion Effect; Sebotek has about +20 to 22 dB of Occlusion Effect; and Vivatone has about +2 dB of Occlusion Effect (with 1.61 SE value).
Thus, it is evident from the data of TABLE 3 that positioning the tested exemplary Vivatone receiver unit into the ear causes the patient's voice level (from a voiced sound “ee”) to change no more than about 2 dB. As discussed above, a 2 dB change might be considered clinically insignificant and unnoticeable, while increases of more than 6 dB might be considered very annoying and very evident to the user.
According to the data in TABLE 3, the second instrument with least occlusion effect is GHI, which causes an occlusion effect in the 8-10 dB range. The Oticon instrument produced 12 to 16 dB of Occlusion Effect and the Seboteck instrument resulted in 20 to 22 dB of Occlusion Effect.
This is supported in TABLE 9, which provides the subjective data gathered from test patients with regard to perceived Occlusion Effect. Review of TABLE 9 shows that the Vivatone device has a rating near 0 (zero), the GHI device has a rating of 1.23, the Oticon device has a rating of 2.68, and the Sebotek device has a rating of 3.32.
With reference to TABLE 5, the following interpretive summary of data across the tested relevant frequencies might apply with regard to the correlation between insertion loss and the size of the receiver unit in the presently described open ear configuration. A casual assessment of the data from TABLE 5 reveals: None (with nothing in the ear canal), 0 dB of insertion loss; the Vivatone receiver unit tested for Group A (with Ø=0.149 inches), no more than about 2 dB of insertion loss; with Ø=0.170 inch receiver unit, no more than about 2.2 dB of insertion loss; with Ø=0.190 inch receiver unit, no more than about 4 dB of insertion loss; and with Ø=0.210 inch receiver unit, no more than about 5.7 dB of insertion loss.
While exemplary embodiments have been shown and described, various modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustration and not limitation.
The present application claims priority to U.S. patent application Ser. No. 10/241,279, filed Sep. 10, 2002, U.S. patent application Ser. No. 10/325,529, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60/445,034, filed Feb. 5, 2003, U.S. Provisional Patent Application No. 60/514,994, filed Oct. 27, 2003, U.S. patent application Ser. No. 10/773,731, filed Feb. 5, 2004, U.S. Provisional Patent Application No. 60/535,569, filed Jan. 9, 2004 and U.S. patent application Ser. No. 11/124,418, filed May 6, 2005, and U.S. patent application Ser. No. 11/331,842, filed Jan. 13, 2006, the entire contents of each of which are specifically incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60445034 | Feb 2003 | US | |
| 60514994 | Oct 2003 | US | |
| 60535569 | Jan 2004 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11331842 | Jan 2006 | US |
| Child | 12170574 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11124418 | May 2005 | US |
| Child | 11331842 | US | |
| Parent | 10773731 | Feb 2004 | US |
| Child | 11124418 | US | |
| Parent | 10325529 | Dec 2002 | US |
| Child | 11331842 | US | |
| Parent | 10241279 | Sep 2002 | US |
| Child | 10325529 | US |
