Evaluation of the Benefits of Bilateral Fitting in BAHS Users

Bilateral Hearing Loss Clinical Trial

Official title: Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

Clinical Trial Description

The patients included in this study are adult patients with a bilateral conductive or mixed hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1) and an auditory working memory test (visit 2). These two outcome measures are conducted in the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday life with their own devices. This is a post market study and all products used are CE marked and used in clinical practice worldwide. ;

Related Conditions & MeSH terms

• Bilateral Hearing Loss
• Hearing Loss
• Hearing Loss, Bilateral

• NCT number: NCT04006132
• Study type: Interventional
• Source: Oticon Medical
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Completion date: January 10, 2020