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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT05284903
Brief Summary:
This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users.
Detailed Description:
Hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. The main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. Evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. However, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources.
This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:
* Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
* Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
* Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user
Study:
NCT05284903
Study Brief:
Protocol Section:
NCT05284903