Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00582946|
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : October 3, 2016
Last Update Posted : November 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impairment||Device: Hearing Aid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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.
- Maximum Effective Sound Pressure Level (MEPO) [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582946
|United States, California|
|Ear Lens Corporation|
|Redwood City, California, United States, 94063|
|Principal Investigator:||Sunil Puria||Ear Lens Corporation|