BC107
Research type
Research Study
Full title
Investigating hearing with Ponto 3 SuperPower, a bone anchored hearing solution.
IRAS ID
293840
Contact name
John FitzGerald
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Research Summary
This is a retrospective study, only collecting already obtained data from clinical routine visits. The study collects hearing-related measurements on Ponto 3 SuperPower, a sound processor that is designed to improve hearing for patients with certain types of hearing losses. The study is part of investigating the real-world benefits of using the Ponto 3 SuperPower, which is a requirement on device manufacturers, and is part of Oticon Medical’s (device manufacturer) Post Market Clinical Follow (PMCF) activity. The participating site is Norfolk and Norwich University Hospital in England. Data will be collected retrospectively from adult patients (18 and above), who were already fitted with Ponto 3 SuperPower (CE-marked and available on the market since 2016). The subject will not participate in any study visits, instead investigator will collect relevant data retrospectively from or just prior to the clinical routine visit when the Ponto 3 Superpower was fitted, and from the follow-up visit(s) which have been performed approximately 3 months after the fitting visit. The data will be collected by the investigators, belonging to the patients' normal healthcare team, during the first half-year of 2021.
The overall objectives of the study are to investigate the improvement in hearing with the Ponto 3 SuperPower(s) in terms of the patients’ ability to hear sounds and understand speech when using the device.
Data will be collected for inclusion/exclusion criteria, eligibility, subject characteristics, regular hearing test, speech test with the device on/off, hearing test with the device on, questionnaire answers, usage hours and skin reactions, if any. Data will only be collected from the audiology files.
As there are no study visits there are no risk for the patients participating in the study.Summary of Results
Title of the clinical Investigation:
Investigating hearing with Ponto 3 SuperPower, a bone anchored hearing aid.Short introduction:
Oticon Medical started developing percutaneous bone anchored hearing systems in 2009. The Ponto 3 SuperPower was introduced in the market in December 2016 by Oticon Medical, which is the most powerful sound processor in the Ponto family with a fitting range up to 65 dB HL. The aim of this study was to gather knowledge about users’ performance with Ponto 3 SuperPower. The sound processor was fitted prior to the study and the data were collected from already performed routine clinical visits when the sound processor was fitted.The purpose of the clinical investigation:
The main objective of the study was to investigate the improvement in hearing with the Ponto 3 SuperPower sound processor for patients with conductive and mixed hearing losses, based on the improvement in hearing thresholds and speech intelligibility. Additionally, the study sought to evaluate the perceived subjective benefit of using of the Ponto 3 SuperPower in patients with conductive- and mixed hearing loss, and single sided deafness.Study design:
This study analysed existing data of Ponto 3 SuperPower users collected from previous clinical routine visits in which data was collected according to the clinic’s normal procedures. The data was collected from clinical routine visit where the Ponto 3 SuperPower was fitted, and the clinical routine follow-up visit approximately 3 months later. The Ponto 3 SuperPower had been on the market for approximately 4 years when the study started, therefore, enrolment was spread over the 4 years to include patients fitted with Ponto 3 SuperPower at the clinic over time. In total, 55 patients were included in the study, of whom 49 had conductive and mixed hearing losses and 6 had single-sided deafness. Data collected were hearing levels with and without the Ponto 3 SuperPower, speech recognition scores measured in quiet and noisy listening environments using the Ponto 3 SuperPower, and a questionnaire to assess patients' perceived benefit from using the sound processor.Results:
• A substantial improvement in hearing levels was obtained when using the Ponto 3 SuperPower compared to the unaided condition for patients with conductive and mixed hearing losses.
• High speech recognition scores were obtained using the Ponto 3 SuperPower in quiet and noisy listening environments at normal speech levels for patients with conductive and mixed hearing losses.
• High scores were obtained in the questionnaire to evaluate the patients’ perceived benefit of using a sound processor, indicating that patients with conductive- and mixed hearing loss, and single sided deafness perceived an improvement in their health-related quality of life with the use of the Ponto 3 SuperPower.Conclusion:
This study showed that the Ponto 3 SuperPower sound processor provided an improved hearing for patients with conductive and mixed hearing losses within intended indication in terms of hearing levels and speech understanding. Additionally, patients with conductive- and mixed hearing loss, and single sided deafness perceived a subjective benefit from using the Ponto 3 SuperPower.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0020
Date of REC Opinion
12 Feb 2021
REC opinion
Further Information Favourable Opinion