Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Primary Purpose
Hearing Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Impairment focused on measuring Hearing Loss, Eardrum, Transducer, Hearing in Noise
Eligibility 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
Sites / Locations
- Ear Lens Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic Contact Hearing Aid
Arm Description
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.
Outcomes
Primary Outcome Measures
Maximum Effective Sound Pressure Level (MEPO)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00582946
First Posted
December 19, 2007
Last Updated
September 30, 2016
Sponsor
EarLens Corporation
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00582946
Brief Title
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Official Title
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
EarLens Corporation
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
Keywords
Hearing Loss, Eardrum, Transducer, Hearing in Noise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Contact Hearing Aid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Intervention Description
Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.
Primary Outcome Measure Information:
Title
Maximum Effective Sound Pressure Level (MEPO)
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Puria
Organizational Affiliation
Ear Lens Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ear Lens Corporation
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Please see publication for summary results.
Citations:
PubMed Identifier
20116419
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2974567/
Description
Electromagnetic EarLens system published in Hearing Research
Learn more about this trial
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
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