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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3

Conditions
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Ability, Spatial

Intervention / Treatment
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* Procedure: Effect of several processing on the auditory distance perception


Participation Criteria
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Eligibility Criteria
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Participants fulfilling any of the following inclusion criteria are eligible for the study: Adult persons (minimum age: 18 years) Healthy outer ear (without previous surgical procedures, except cochlear implantation) Ability to fill in a questionnaire conscientiously Informed Consent as documented by signature Normal hearing participants • Adult persons with audiometric normal hearing thresholds Hearing impaired participants Adult hearing impaired persons with and without (experience with) hearing aids Adult hearing impaired persons with cochlear implant(s) The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product Limited mobility and not in the position to attend weekly appointments Limited ability to describe listening impressions/experiences and the use of the hearing aid Inability to produce a reliable hearing test result Massively limited dexterity Known psychological problems Known central hearing disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: a group of normal hearing and hearing-impaired participants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: normal-hearing and hearing-impaired participants<br>normal and hearing-impaired participants | Procedure: Effect of several processing on the auditory distance perception<br>* The focus is a comparison of hearing instrument algorithms on the auditory distance perception<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the distance discrimination | 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. | 8 weeks |