Trial record 1 of 1 for:    NCT01715948
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Comparison of BAHA and CROS Hearing Aid in Single-Sided Deafness

This study has been completed.
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Manohar Bance, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01715948
First received: October 23, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

People with single-sided deafness (SSD) have significant hearing loss in one ear and normal or near normal hearing in the other ear. Those living with SSD experience several communication difficulties, particularly when listening to speech in the presence of background noise. This problem is worse in situations where the noise is on the side of the good ear and the speech is on the side of the poor ear.

The Bone-Anchored Hearing Aid (BAHA) and the Contralateral Routing of Signals (CROS) hearing aid are two devices designed to improve hearing in people who have significant hearing loss in one ear only. The BAHA is a surgically implanted device which also includes an external processor; sounds from the poor ear are transmitted to the good ear through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the good ear.

The majority of previous studies comparing the BAHA to the CROS have used older CROS models with basic technology and a wire along the neck to send sounds from the poor ear to the good ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the BAHA. The current research will compare the effect of the BAHA and CROS hearing aid on speech perception scores when listening to speech in quiet and in noise. The research will also investigate patients' reported benefits with each device during everyday situations. In order to compare the BAHA and CROS, individuals who already have been implanted with a BAHA will be given a trial period with a new wireless digital CROS hearing aid.

The research hypothesis states that the CROS hearing aid will be as equally beneficial or greater than the BAHA in improving hearing and patient benefit. If the findings support the hypothesis that the CROS offers just as much benefits as the BAHA, or is an even better alternative, more patients may choose to avoid surgery and decide to receive a CROS hearing aid instead.


Condition Intervention
Unilateral Hearing Loss
Unilateral Deafness
Device: CROS hearing aid

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of BAHA and CROS Hearing Aid in Single-Sided Deafness

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Change in Speech-in-noise (QuickSIN) test scores [ Time Frame: The QuickSIN will be administered unaided (no device) during the first visit to the clinic, and will be administered again at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ] [ Designated as safety issue: No ]
    The QuickSIN is a speech in noise test. Participants are asked to repeat sentences while listening in multi-talker background noise.


Secondary Outcome Measures:
  • Bern Benefit in Single-Sided Deafness Questionnaire (BBSS) [ Time Frame: Will be administered at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ] [ Designated as safety issue: No ]
    The BBSS is a 10-item questionnaire that measures participants' perceived benefit from their BAHA or CROS hearing aid. The items examine different situations in which participants score the benefit derived from their device with ratings that range from -5 ("Much Easier Without the Aid") to +5 ("Much Easier With the Aid").

  • Speech Spatial Qualities Questionnaire (SSQ) [ Time Frame: Will be administered at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ] [ Designated as safety issue: No ]
    The Speech Spatial Qualities Questionnaire describes 49 scenarios in which participants may experience difficulty hearing. For both the BAHA and CROS, participants will be asked to rate their perceived hearing ability for all scenarios on a 10-point scale, ranging from "Not at all" to "Perfectly".


Enrollment: 9
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CROS hearing aid
Patients who have been implanted with a BAHA over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.
Device: CROS hearing aid
BAHA users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHA over a two-week period.
Other Name: Unitron Tandem 4 CROS hearing aid

Detailed Description:

Users of BAHA will be given a 2-week trial period with the Unitron Tandem CROS hearing aid. Participants will be randomly assigned to wear either their BAHA for two weeks or the trial CROS for two weeks. There will be a total of three visits made to the clinic.

During each visit:

  • Participants' hearing will be tested (either with the BAHA, the CROS, or without wearing any device).
  • Speech perception ability will be tested in quiet and in noise conditions (either while wearing the BAHA, the CROS, or no device).
  • Participants will be asked to complete two standardized questionnaires on the perceived benefits that the BAHA or the CROS provides.

In addition, participants will be asked to fill out a short diary form every day, for a two-week period, to report the situations in which they wore the device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with unilateral deafness (hearing loss in only one ear) who received BAHA surgery less than 3 years ago
  • Severe to profound hearing loss in the poor ear and normal hearing in the good ear
  • English speaking

Exclusion Criteria:

  • Adults who underwent BAHA surgery more than 3 years ago
  • Adults with hearing loss in both ears
  • Adults who received a BAHA to treat a condition other than unilateral deafness (such as bilateral conductive hearing loss)
  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: NCT01715948

Locations
Canada, Nova Scotia
School of Human Communication Disorders
Halifax, Nova Scotia, Canada, B3J 1Y6
Sponsors and Collaborators
Manohar Bance
Dalhousie University
Investigators
Principal Investigator: Manohar Bance, FRCS Capital Health, Canada
Principal Investigator: Rachel Caissie, Ph.D. Dalhousie University
Principal Investigator: Jennifer Finbow, B.Sc. Dalhousie University
  More Information

No publications provided

Responsible Party: Manohar Bance, Staff Physician Division of Otolaryngology, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01715948     History of Changes
Other Study ID Numbers: CDHA-RS/2013-118
Study First Received: October 23, 2012
Last Updated: July 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
CROS hearing aid
Bone-anchored hearing device

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

ClinicalTrials.gov processed this record on October 19, 2014