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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT01715948
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: October 2013