Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT04006132
Brief 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).
Detailed 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.
Study:
NCT04006132
Study Brief:
Protocol Section:
NCT04006132