Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

Bilateral Hearing Loss Clinical Trial

Official title: Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

Status Terminated

Clinical Trial Summary

The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.

Clinical Trial Description

Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings (OpenSound Navigator ON and OFF) of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty (i.e., in terms of signal-to-noise ratio, SNR). Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient's own device). All these outcome measures are non-invasive measurements. 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: NCT04242940
• Study type: Interventional
• Source: Oticon Medical
• Status: Terminated
• Phase: N/A
• Start date: February 21, 2020
• Completion date: May 17, 2022