Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
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|ClinicalTrials.gov Identifier: NCT00201617|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment|
|Unilateral Deafness||Device: Bone-anchored hearing aid|
Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.
This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.
Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Observational Model:||Case Control|
|Official Title:||Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness|
|Study Start Date :||July 2004|
|Actual Study Completion Date :||August 2007|
normal hearing sensitivity
Unilateral deafness who are implanted with a Bone Anchored Hearing Aid
|Device: Bone-anchored hearing aid|
- HINT score [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA ]Hearing in Noise Test
- CNC score [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA ]Consonant-nucleus-consonant speech-recognition test
- Localization [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA ]Localization in sound field test
- Abbreviated Profiles of Hearing Aid Benefit [ Time Frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA ]Questionnaire
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): NCT00201617
|United States, New York|
|New York Eye & Ear Infirmary|
|New York, New York, United States, 10003|
|Principal Investigator:||Christopher J Linstrom, MD||New York Eye & Ear Infirmary|
|Principal Investigator:||Carol A Silverman, PhD, MPH||New York Eye & Ear Infirmary|