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Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding

NCT ID: NCT00582946

Last Updated: 2016-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-12-31

Brief Summary

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Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.

Detailed Description

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Conditions

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Hearing Impairment

Keywords

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Hearing Loss, Eardrum, Transducer, Hearing in Noise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Magnetic Contact Hearing Aid

Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.

Group Type EXPERIMENTAL

Hearing Aid

Intervention Type DEVICE

Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.

Interventions

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Hearing Aid

Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hearing loss less than 60 dB at any frequency, no conductive hearing loss

Exclusion Criteria

* Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

EarLens Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Suzy Levy, Ph.D.

Director of Clinical, For Sunil Puria, Chief Scientist (no longer with company)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunil Puria

Role: PRINCIPAL_INVESTIGATOR

Ear Lens Corporation

Locations

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Ear Lens Corporation

Redwood City, California, United States

Site Status

Countries

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United States

References

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Perkins R, Fay JP, Rucker P, Rosen M, Olson L, Puria S. The EarLens system: new sound transduction methods. Hear Res. 2010 May;263(1-2):104-13. doi: 10.1016/j.heares.2010.01.012. Epub 2010 Jan 29.

Reference Type RESULT
PMID: 20116419 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2974567/

Electromagnetic EarLens system published in Hearing Research

Other Identifiers

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R44DC008499

Identifier Type: NIH

Identifier Source: secondary_id

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R43DC008499-01

Identifier Type: NIH

Identifier Source: org_study_id

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