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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Suzy Levy, Ph.D., EarLens Corporation
ClinicalTrials.gov Identifier:
NCT00582946
First received: December 19, 2007
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Hearing Impairment
Device: Hearing Aid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding

Resource links provided by NLM:


Further study details as provided by EarLens Corporation:

Primary Outcome Measures:
  • Maximum Effective Sound Pressure Level (MEPO) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.


Enrollment: 16
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Hearing Aid
Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582946

Locations
United States, California
Ear Lens Corporation
Redwood City, California, United States, 94063
Sponsors and Collaborators
EarLens Corporation
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Sunil Puria Ear Lens Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Suzy Levy, Ph.D., Director of Clinical, For Sunil Puria, Chief Scientist (no longer with company), EarLens Corporation
ClinicalTrials.gov Identifier: NCT00582946     History of Changes
Other Study ID Numbers: R43DC008499-01  R44DC008499 
Study First Received: December 19, 2007
Results First Received: October 29, 2013
Last Updated: September 30, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Please see publication for summary results.

Keywords provided by EarLens Corporation:
Hearing Loss, Eardrum, Transducer, Hearing in Noise

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 09, 2016