ASHA Asks FDA to Investigate Hearing Device Sales

Objective The efficacy of the Otologics Fully Implantable Hearing Device (MET) was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. Methods Surgical insertion of this totally implanted system was identical to the Phase I study. A repeated-measures within-subjects design assessed aided sound field thresholds and speech performances with the subject's own, appropriately fit, walk-in hearing aid(s) and the Otologics Fully Implantable Hearing Device. Results Six- and 12-month Phase II data will be presented. Ten patients were implanted and activated as part Phase II clinical trial. Three patients were lost to long term follow-up due to two coil failures and one ossicular abnormality preventing proper device placement. No significant differences between preoperative (AC = 59 dB, BC = 55 dB) and postoperative (AC = 61 dB, BC = 54 dB) unaided pure tone averages were noted (p < 0.05). Pure tone average implant aided thresholds (41 dB) were equivalent to that of walk-in-aided (37 dB) condition with no significant difference (p < 0.05) between patients’ walk-in-aided individual frequency thresholds and implant-aided thresholds. Word recognition scores and hearing in noise scores were similar between the walk-in-aided and for the implant-aided condition. Patient benefit scales will be presented at all end points. Conclusions Results of the Otologics MET Fully Implantable Hearing Device Phase II trial provide evidence that this fully implantable device is a viable alternative to currently available hearing aids in patients with sensorineural hearing loss.

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Application of an Implantable Bone Conduction Hearing Device to Patients With Unilateral Sensorineural Hearing Loss

The Laryngoscope ◽

10.1288/00005537-199205000-00013 ◽

1992 ◽

Vol 102 (5) ◽

pp. 538-542 ◽

Cited By ~ 8

Author(s):

Bruce A. Weber ◽

Jackson Roush ◽

John T. McElveen

Keyword(s):

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Bone Conduction ◽

Sensorineural Hearing ◽

Hearing Device ◽

Bone Conduction Hearing

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A microminiature electromagnetic middle-ear implant hearing device

Sensors and Actuators A Physical ◽

10.1016/0924-4247(94)00967-m ◽

1995 ◽

Vol 47 (1-3) ◽

pp. 584-587 ◽

Cited By ~ 14

Author(s):

W. Affane ◽

T.S. Birch

Keyword(s):

Middle Ear ◽

Middle Ear Implant ◽

Hearing Device

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Quality of Life in Children with Sensorineural Hearing Loss

Otolaryngology ◽

10.1177/0194599819886122 ◽

2019 ◽

Vol 162 (1) ◽

pp. 129-136 ◽

Cited By ~ 1

Author(s):

Evette A. Ronner ◽

Liliya Benchetrit ◽

Patricia Levesque ◽

Razan A. Basonbul ◽

Michael S. Cohen

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Normal Hearing ◽

Sensorineural Hearing ◽

Significant Difference ◽

Pedsql 4.0 ◽

Hearing Device ◽

Prospective Longitudinal

Objective To assess quality of life (QOL) in pediatric patients with sensorineural hearing loss (SNHL) with the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) and the Hearing Environments and Reflection on Quality of Life 26 (HEAR-QL-26) and HEAR-QL-28 surveys. Study Design Prospective longitudinal study. Setting Tertiary care center. Subjects and Methods Surveys were administered to patients with SNHL (ages 2-18 years) from July 2016 to December 2018 at a multidisciplinary hearing loss clinic. Patients aged >7 years completed the HEAR-QL-26, HEAR-QL-28, and PedsQL 4.0 self-report tool, while parents completed the PedsQL 4.0 parent proxy report for children aged ≤7 years. Previously published data from children with normal hearing were used for controls. The independent t test was used for analysis. Results In our cohort of 100 patients, the mean age was 7.7 years (SD, 4.5): 62 participants had bilateral SNHL; 63 had mild to moderate SNHL; and 37 had severe to profound SNHL. Sixty-eight patients used a hearing device. Mean (SD) total survey scores for the PedsQL 4.0 (ages 2-7 and 8-18 years), HEAR-QL-26 (ages 7-12 years), and HEAR-QL-28 (ages 13-18 years) were 83.9 (14.0), 79.2 (11.1), 81.2 (9.8), and 77.5 (11.3), respectively. Mean QOL scores for patients with SNHL were significantly lower than those for controls on the basis of previously published normative data ( P < .0001). There was no significant difference in QOL between children with unilateral and bilateral SNHL or between children with SNHL who did and did not require a hearing device. Low statistical power due to small subgroup sizes limited our analysis. Conclusion It is feasible to collect QOL data from children with SNHL in a hearing loss clinic. Children with SNHL had significantly lower scores on validated QOL instruments when compared with peers with normal hearing.

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Vibrant Soundbridge Implantable Hearing Device: Critical Review and Single-Surgeon Short- and Long-Term Results

Ear Nose & Throat Journal ◽

10.1177/014556131008900903 ◽

2010 ◽

Vol 89 (9) ◽

pp. E9-E14 ◽

Cited By ~ 5

Author(s):

Charles M. Luetje ◽

Sandra A. Brown ◽

Robert D. Cullen

Keyword(s):

Middle Ear ◽

Final Analysis ◽

Senior Author ◽

Long Term Results ◽

Direct Drive ◽

Vibrant Soundbridge ◽

Short And Long Term ◽

Hearing Device

We conducted a retrospective descriptive study of a series of 31 consecutively presenting patients who had been implanted with the Vibrant Soundbridge middle ear hearing device. All implantations had been performed by the senior author. Three of these patients had undergone bilateral implantation, and 4 others had undergone subsequent explantation and reimplantation in response to known or suspected device failure, giving us a total of 34 ears and 38 implants. Our goal was to ascertain short- and long-term outcomes as measured by conventional audiometry (pure-tone average at 1 to 6 kHz) and long-term benefit as defined by the use or nonuse of the device. We found that at the initial activation session 2 months postoperatively, the average hearing thresholds were within 3 dB of the preoperative thresholds in all 34 ears and all 38 implants. The mean short-term gain at activation in the 38 implants was 28.1 dB. Nineteen patients (20 ears) were available for long-term evaluation, with the length of follow-up ranging from less than 1 year to 11 years (mean: 7.3). Of these 20 ears, 9 demonstrated further gain (mean: 10.8 dB) despite any natural hearing deterioration; of the remaining 11 ears, gain was unchanged in 2, diminished in 7 (mean: −3.6 dB), and gain data were unavailable in 2. In the final analysis, there were 20 user ears and 10 nonuser ears; 4 ears were lost to all follow-up. We conclude that direct-drive hearing with the Vibrant Soundbridge middle ear hearing device is beneficial and provides sustained audiometric gain. Factors that have a significant impact on patient use or nonuse include difficulty in obtaining audiologic support and the direct and indirect costs of the device. Without audiologic or financial support, some patients may choose to become nonusers and to either switch to conventional hearing aid amplification or become apathetic about hearing improvement.

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Semi-implantable Middle Ear Electromagnetic Hearing Device for Sensorineural Hearing Loss

Ear Nose & Throat Journal ◽

10.1177/014556139707600510 ◽

1997 ◽

Vol 76 (5) ◽

pp. 333-341 ◽

Cited By ~ 20

Author(s):

Anthony J. Maniglia ◽

Wen H. Ko ◽

Steven L. Garverick ◽

Hassan Abbass ◽

Michael Kane ◽

...

Keyword(s):

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Middle Ear ◽

Subjective Evaluation ◽

The Body ◽

Sensorineural Hearing ◽

Rf Amplifier ◽

Audio Amplifier ◽

Receiving Antenna ◽

Hearing Device

A semi-implantable middle ear electromagnetic hearing device (SIMEHD) is proposed for limited clinical trial in adult patients to evaluate the implantable hearing device for moderate to severe sensorineural hearing loss. Food and Drug Administration (FDA) investigational device exemption (IDE) approval has been granted (May 1996) for clinical trials. The implant unit has been evaluated acutely and chronically in animals (cats) with excellent results. Five cats undergoing chronic implantation were allowed to survive an average of 9.6 months, showing that the SIMEHD is biocompatible, functional and without untoward complications. All implant units recovered from the cats were functional, except for wire breakage of the internal antenna. A new antenna was redesigned for human implantation. The SIMEHD system consists of an external and internal unit. The external unit consists of a microphone, audio amplifier, modulator, radio frequency (RF) amplifier, antenna and battery. The internal unit is composed of a receiving antenna, hybrid electronic circuit, air core driving coil, and a target magnet cemented to the incus. All materials in contact with the body are biocompatible and expected to survive indefinitely. The implant unit is miniaturized and manufactured with existing fabrication technology by our industrial collaborator, Wilson Greatbatch, Ltd. The specific aims and major tasks of the proposed research are: a) to evaluate reliability, safety and efficacy of the SIMEHD system in a selected group of patients diagnosed with sensorineural hearing loss, due mainly to presbycusis or aging of the inner ear; and b) to obtain objective and subjective evaluation of audiologic and psychoacoustic performance as compared to the acoustic hearing aid. This paper describes the design, illustrates the actual device (newest prototype) and details the technique for surgical implantation in the attic and mastoid antrum in humans.

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