Efficacy of a Combination Hearing Aid and Sound Generator for tinnitus
Research type
Research Study
Full title
Efficacy of a Combination Hearing Aid and Sound Generator for tinnitus
IRAS ID
170176
Contact name
David M. Baguley
Contact email
Sponsor organisation
Oticon A/S
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
The effect of using a combination device, meaning a hearing instrument with a tinnitus sound generator, versus a conventional hearing instrument alone to provide tinnitus relief has not been explored extensively at this point in time. This study will investigate whether the Oticon Tinnitus SoundSupport (TSS) feature in the Oticon combination device, Alta2 Pro Ti, can provide relief from tinnitus in patients with some degree of hearing loss.
Specifically, the aim is to investigate the amount of relief from tinnitus of the Alta2 Pro Ti, over and above a conventional hearing instrument alone. The primary measure is the Tinnitus Functional Index (TFI) questionnaire. A framework of the standard care of practice in diagnostics, counseling, and sleep management is assumed.
The study will also observe: ease of use for patients, ease of use for the clinician, usage of the hearing instrument with the TSS feature enabled, usage variables (duration of use, location of use), settings variables (specific preferences of noise types, signal levels, use of modulation, selection of ocean sounds) and patient variables related to emotional state. These outcomes will be measured using a variety of questionnaires and data logging built within the combination device.
One coordinated study will be conducted at two sites: Cambridge University Hospitals NHS Foundation Trust in England under the supervision and direction of Dr. David Baguley, and the Cleveland Clinic in Ohio under the supervision and direction of Dr. Craig Newman and Dr. Sharon Sandridge.
One test group and one control group will be recruited from each test site: 80 participants in total, with an equal number of participants in each of the 4 groups. The study is predicted to run over the course of six months.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0169
Date of REC Opinion
22 May 2015
REC opinion
Favourable Opinion