Comparison of BAHA and CROS Hearing Aid in Single-Sided Deafness

Unilateral Deafness Clinical Trial

Official title:

Comparison of BAHA and CROS Hearing Aid in Single-Sided Deafness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715948
• Other study ID #: CDHA-RS/2013-118
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: July 24, 2014
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Unilateral
• Unilateral Deafness
• Unilateral Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Canada	School of Human Communication Disorders	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Manohar Bance	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Speech-in-noise (QuickSIN) test scores	The QuickSIN is a speech in noise test. Participants are asked to repeat sentences while listening in multi-talker background noise.	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.	No
Secondary	Bern Benefit in Single-Sided Deafness Questionnaire (BBSS)	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").	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.	No
Secondary	Speech Spatial Qualities Questionnaire (SSQ)	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".	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.	No