Trial record 1 of 1 for:    NCT01264510
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Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01264510
First received: April 22, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Conductive Hearing Loss
Mixed Hearing Loss
Unilateral Deafness
Other: audiological test battery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles [ Time Frame: after 3 months up to 10 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patients implanted with a Bone-anchored hearing aid(Baha) Other: audiological test battery
routine audiological measurements.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264510

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Ingeborg Dhooge, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01264510     History of Changes
Other Study ID Numbers: 2010/074
Study First Received: April 22, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Unilateral
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014