Clinical trial NCT00201617: Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
Official title: Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unilateral Deafness
Keywords: Unilateral hearing loss
Unilateral deafness
Bone anchored hearing aid
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
Collaborators: name: The Jacob and Valeria Langeloth Foundation
First posted: 2005-09-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult-onset deafness
2. Deafness is unilateral - complete or near complete

Exclusion Criteria:

1. the presence of a developmental disorder or mental retardation;
2. history of drug abuse;
3. psychiatric disease;
4. inability to follow instructions or to participate in follow-up appointments
5. inability to use the BAHA
6. lack of osseo-integration -

Primary outcomes:
measure: HINT score
timeFrame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
measure: CNC score
timeFrame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
measure: Localization
timeFrame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA
Secondary outcomes:
measure: Abbreviated Profiles of Hearing Aid Benefit
timeFrame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye & Ear Infirmary
state: New York
Study officials:
affiliation: New York Eye & Ear Infirmary
name: Christopher J Linstrom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Eye & Ear Infirmary
name: Carol A Silverman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: