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Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

Conductive Hearing Loss Clinical Trial

Official title:
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

Clinical Trial Summary

The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits. The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study. Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016. The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower. The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04803279
Study type Observational
Source Oticon Medical
Contact liselotte borup
Phone +45 41241964
Email liselotteborup@yahoo.dk
Status Recruiting
Phase
Start date March 16, 2021
Completion date May 31, 2021
View Details
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