Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2

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 2

Conditions
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Ability, Spatial

Intervention / Treatment
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* Procedure: several virtual 3-D complex audio environments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult persons (minimum age: 18 years) with Hearing loss Healthy outer ear (without previous surgical procedures) Ability to fill in a questionnaire conscientiously Informed Consent as documented by signature Exclusion Criteria: 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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No

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 hearing-impaired particpants with mild or severe hearing loss
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hearing impaired participants<br>Hearing impaired participants with mild or severe hearing loss | Procedure: several virtual 3-D complex audio environments<br>* The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head movements measured with head tracker | The participant starts the acoustic stimulus, tries to identify the direction of the stimulus as precise as possible and validates the final position. This is interpreted as reaction time with regard to spatial quality in seconds [s]. | 6 weeks |