N/A
N=9
A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study
Unilateral Hearing Loss · Unilateral Deafness
Bottom Line
View on ClinicalTrials.gov: NCT01715948 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise — 5.44; 3.5; 4.75; -1.75 words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CROS hearing aid (Device); Bone-anchored hearing device (BAHD) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Manohar Bance
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise |
5.44; 3.5; 4.75; -1.75; 0.75; 2.38 | — |
| PRIMARY Percentage of Words Recognized |
48.5; 78; 96; 62.5; 77; 97 | — |
| PRIMARY Speech Spatial Qualities Questionnaire (SSQ) |
5.56; 5.79; 4.24; 4.45; 6.89; 7.12 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01715948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.