NCT00201617

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

First QC Date

September 12, 2005

Last Update Submit

April 13, 2015

Conditions

Unilateral Deafness

Keywords

Unilateral hearing lossUnilateral deafnessBone anchored hearing aid

Outcome Measures

Primary Outcomes (3)

  • HINT score

    Hearing in Noise Test

    Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA

  • CNC score

    Consonant-nucleus-consonant speech-recognition test

    Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA

  • Localization

    Localization in sound field test

    Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA

Secondary Outcomes (1)

  • Abbreviated Profiles of Hearing Aid Benefit

    3 months post BAHA, 6 months post BAHA, 1 year post BAHA

Study Arms (2)

1

normal hearing sensitivity

2

Unilateral deafness who are implanted with a Bone Anchored Hearing Aid

Device: Bone-anchored hearing aid

Interventions

Bone-anchored hearing aidDEVICE
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Eye & Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher J Linstrom, MD

    New York Eye & Ear Infirmary

    PRINCIPAL INVESTIGATOR

  • Carol A Silverman, PhD, MPH

    New York Eye & Ear Infirmary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Study Completion

August 1, 2007

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

US(1)