Evaluation of the benefits of bilateral fitting in BAHS users - v1
Research type
Research Study
Full title
Evaluation of the benefits of bilateral fitting in bone-anchored hearing system users
IRAS ID
251449
Contact name
William Brassington
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
C71 study: Evaluation of the benefits of bilateral fitting in bone-anchored hearing system users
This single-blinded, repeated measures, crossover study will be conducted at the Queen Elizabeth, University Hospitals Birmingham. The study is designed to collect data from 20-25 adult patients with a conductive or mixed conductive-sensorineural hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). After fitting, the patients will participate in three outcome measures: a localization test (minimum audible angle), a speech and memory test (BKB and SWIR tests), and a questionnaire (SSQ12). The first two outcome measures will be conducted in clinical space using the investigational device (Ponto 3 SupePower) unilaterally and bilaterally. The questionnaire will, instead, reflect the patients’ performance with their own device.
The primary objective of this study is to evaluate the difference in minimum audible angle, when localizing sounds with one Ponto 3 SuperPower (unilateral condition) relative to two Ponto 3 SuperPower (bilateral condition). The secondary objectives are: 1) to evaluate the difference in working memory using Ponto 3 SuperPower unilaterally vs bilaterally; 2) to evaluate the subjective benefit of using bilateral Ponto in everyday life via the SSQ12 questionnaire.
The purpose of this study is to evaluate the benefit of bilateral implantation in everyday life, in terms of localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS will improve localization abilities, as well as the ability to retain words in working memory, as a consequence of a better sound quality obtained with two devices.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0355
Date of REC Opinion
23 Feb 2019
REC opinion
Favourable Opinion