BC106 Ponto 4 PMCF1
Research type
Research Study
Full title
To investigate the improvement in hearing with the bone anchored hearing solution Ponto 4 on the implanted ear(s).
IRAS ID
279825
Contact name
John FitzGerald
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
BC106 study: Ponto 4 PMS1 Study
Summary
This multi-center, single-blinded, prospective study will be conducted at the Norfolk and Norwich University Hospital and University Hospital Bristol. The study is designed to collect data from 34 adult patients with a conductive, mixed hearing loss or single-sided deafness, that are already using a bone-anchored hearing solution (BAHS).
The purpose of this study is to study the outcome in hearing in terms of ability to hear sounds and understand speech when using Ponto 4, a CE marked bone anchored hearing solution, launched by Oticon Medical AB in June 2019. This will be evaluated through speech tests in quiet and in noise as well as assess the hearing with Ponto 4(s) on and off. Additionally, a patient reported outcome questionnaire evaluating the performance with the Ponto 4(s) after usage in various daily listening situations will be collected from each subject.
The study consists of 2 visits, Visit 1 and Visit 2 each of approximately 2-2 ½ hours in duration. In between the 2 visits there will be a field trial period of 4-6 weeks where the subject will be asked to use the Ponto 4(s), instead of their own BAHS, in their everyday listening situations.
At Visit 1, an audiometry (hearing test) will be measured to evaluate whether the subject is eligible for the study. If the subject is found eligible, the Ponto 4 is fitted to the subjects hearing loss following the recommended fitting protocol. A speech in noise test will then be performed with the Ponto 4(s) programmed in two different settings. Subjects will conduct a 4-6 weeks trial period of the Ponto 4(s): between Visit 1 and Visit 2, and they will be asked to fill out a questionnaire regarding their everyday experience with the Ponto 4(s) by the end of this period.
At Visit 2, the research team will collect the questionnaire and ask subjects to estimate their everyday usage hours of the Ponto 4(s). Speech test in quiet will be conducted with and without the Ponto 4(s). Sound field audiometry will also be performed (hearing test with loudspeakers), with and without the Ponto 4(s). In the end of visit 2, the test leader will ask which BAHS the subject prefers; their own BAHS or the BAHS they used in the study (Ponto 4(s)). The subject will also be asked if they would like to keep the Ponto 4(s).
34 eligible subjects will be included in the study. If drop-out rate is threatening to jeopardize the power of the study, replacement will be considered and an amendment to the CIP will be prepared accordingly.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0071
Date of REC Opinion
21 Apr 2020
REC opinion
Further Information Favourable Opinion