Clinical trial NCT01715948: A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study
Official title: A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Hearing Loss
Unilateral Deafness
Keywords: CROS hearing aid
Bone-anchored hearing device
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2012-10-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 device (BAHD) and the Contralateral Routing of Signals (CROS) hearing aid are two intervention methods designed to improve hearing in people who have significant hearing loss in one ear only. The BAHD 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 BAHD 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 BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech perception scores when listening to speech in quiet and in noise. The research will also investigate participants' reported benefits with each device during everyday situations. In order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD 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 BAHD in improving hearing and participant benefit. If the findings support the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better alternative, more individuals with SSD may choose to avoid surgery and decide to receive a CROS hearing aid instead.

Detailed description: Users of the BAHD will be given a 2-week trial period with the Unitron Tandem CROS hearing aid. Participants will be randomly assigned to wear either their BAHD 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 BAHD, the CROS, or without wearing any device).
* Speech perception ability will be tested in quiet and in noise conditions (either while wearing the BAHD, the CROS, or no device).
* Participants will be asked to complete two standardized questionnaires on the perceived benefits that the BAHD 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 criteria: Inclusion Criteria:

* Adults with unilateral deafness (hearing loss in only one ear) who received BAHD 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 BAHD surgery more than 3 years ago
* Adults with hearing loss in both ears
* Adults who received a BAHD to treat a condition other than unilateral deafness (such as bilateral conductive hearing loss)

Primary outcomes:
measure: Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise
timeFrame: The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).
measure: Percentage of Words Recognized
timeFrame: Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..
measure: Speech Spatial Qualities Questionnaire (SSQ)
timeFrame: Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Capital Health, Canada
name: Manohar Bance, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Rachel Caissie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Jennifer Finbow, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References: