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

Hearing Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582946
• Other study ID #: R43DC008499-01
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2007
• Last updated: December 19, 2007
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Device:
• Hearing Aid
Amplification of sound for hearing impaired subjects

Locations

Country	Name	City	State
United States	Ear Lens Corporation	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)	House Ear Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Reception Threshold		1 year	Yes
Secondary	Effective Sound Pressure Level, Feedback Gain Margin		1 year	Yes