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Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) (Baha)

Primary Purpose

Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Deafness

Status
Withdrawn
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
audiological test battery
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conductive Hearing Loss focused on measuring conductive hearing loss, mixed hearing loss, unilateral deafness, implanted with Baha, conductive or mixed hearing loss implanted with a Baha or, unilateral deafness implanted with a Baha

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study.
  • Only patients above 18 years will be included.

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients implanted with a Bone-anchored hearing aid(Baha)

Arm Description

Outcomes

Primary Outcome Measures

benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
Patients who are already implanted with a Baha at the University Hospital of Ghent will be re-evaluated once using an audiological test battery. This evaluation will take place at least 3 months after implantation for the recently implanted subjects. For the subjects who are implanted in the past, this evaluation will take place maximum 10 years after implantation. The audiological test battery includes measurements of hearing thresholds, speech understanding in quiet and noise, and auditory orientation tests.

Secondary Outcome Measures

evaluation of subjective benefit of the Baha
The subjective benefit of the Baha in different situations will be evaluated by means of questionnaires. No measures regarding safety, tolerability or pain will be evaluated because these measures are already verified for the Baha. The outcome measures are strictly related to audiological factors (e.g. the difference in hearing thresholds/ speech understanding/ orientation with and without Baha). The test duration is estimated at 2 hours.

Full Information

First Posted
April 22, 2010
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01264510
Brief Title
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
Acronym
Baha
Official Title
The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
reason unknown
Study Start Date
March 2010 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear. Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients. Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Deafness
Keywords
conductive hearing loss, mixed hearing loss, unilateral deafness, implanted with Baha, conductive or mixed hearing loss implanted with a Baha or, unilateral deafness implanted with a Baha

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients implanted with a Bone-anchored hearing aid(Baha)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
audiological test battery
Intervention Description
routine audiological measurements.
Primary Outcome Measure Information:
Title
benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
Description
Patients who are already implanted with a Baha at the University Hospital of Ghent will be re-evaluated once using an audiological test battery. This evaluation will take place at least 3 months after implantation for the recently implanted subjects. For the subjects who are implanted in the past, this evaluation will take place maximum 10 years after implantation. The audiological test battery includes measurements of hearing thresholds, speech understanding in quiet and noise, and auditory orientation tests.
Time Frame
after 3 months up to 10 years
Secondary Outcome Measure Information:
Title
evaluation of subjective benefit of the Baha
Description
The subjective benefit of the Baha in different situations will be evaluated by means of questionnaires. No measures regarding safety, tolerability or pain will be evaluated because these measures are already verified for the Baha. The outcome measures are strictly related to audiological factors (e.g. the difference in hearing thresholds/ speech understanding/ orientation with and without Baha). The test duration is estimated at 2 hours.
Time Frame
after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study. Only patients above 18 years will be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Dhooge, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent

Learn more about this trial

Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

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