NCT01715948

A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Manohar Bance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unilateral Hearing Loss
• Unilateral Deafness

Interventions

Type	Name	Description
DEVICE	CROS hearing aid	Participants were randomly assigned to be fitted with the CROS hearing aid either at the end of the first visit or at the end of the second visit. They were given a 2-week trial with the CROS and asked to refrain from wearing their BAHD during that time. At the end of the first visit, four participants were fitted with the CROS hearing aid and were subsequently tested with this device on their second visit, at which time they were instructed to use the BAHD for the next 2 weeks. This protocol was reversed in the other four participants, with testing after each device experience. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
DEVICE	Bone-anchored hearing device (BAHD)	All participants had received BAHD implantation prior to the study. They were randomly selected to continue wearing their BAHD for 2 weeks following the end of the first visit or the end of the second visit. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-10-29
• Last updated: 2016-04-05
• Results posted: 2016-04-05