CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Hearing Aiddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00582946
NCT00582946Phase 1Completed

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

EarLens Corporation·interventional·Posted Dec 28, 2007·Updated Nov 4, 2016

In Brief

A Phase 1 clinical trial evaluating Hearing Aid for Hearing Impairment. Completed, enrolled 16 participants across 1 site.

Detailed 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 (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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2007
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.5 years ago

Interventions

Hearing Aiddevice

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