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Completed

NCT Number: NCT00201617

Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Eye & Ear Infirmary

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult-onset deafness
  • Deafness is unilateral - complete or near complete

Exclusion criteria

  • the presence of a developmental disorder or mental retardation;
  • history of drug abuse;
  • psychiatric disease;
  • inability to follow instructions or to participate in follow-up appointments
  • inability to use the BAHA
  • lack of osseo-integration -

Treatment and study plan

Bone-anchored hearing aid

Device

Primary outcomes

  1. HINT score

    Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA

    Hearing in Noise Test

  2. 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

  3. Localization

    Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA

    Localization in sound field test

Secondary outcomes

  1. Abbreviated Profiles of Hearing Aid Benefit

    Time frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA

    Questionnaire

Sponsors and collaborators

Lead sponsor

The New York Eye & Ear Infirmary

Other

Collaborators

  • The Jacob and Valeria Langeloth Foundation

Registry information

Official study title

Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness

Important dates

Study start
2004
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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