Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3 (HEAR3D_CE3)

Not Applicable

Completed

• Conditions: Ability, Spatial

• Registration Number: NCT04180254
• Lead Sponsor: Sonova AG

Brief Summary

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strengths and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at the University Hospital of Zürich.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Success rate of the distance discrimination	8 weeks	Participants are asked whether an audio stimulus is closer or further at the end of the stimulus than at its beginning. The success rate is measured as a function of the test conditions.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland