MedPath

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

Not Applicable
Completed
Conditions
Ability, Spatial
Interventions
Procedure: several virtual 3-D complex audio environments
Registration Number
NCT03514758
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Adult normal hearing persons (minimum age: 18 years)
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
normal hearing participantsseveral virtual 3-D complex audio environmentsnormal hearing participants with and without hearing aids
Primary Outcome Measures
NameTimeMethod
Head movements measured with head tracker6 weeks

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 \[s\].

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital Zurich

🇨🇭

Zürich, Switzerland

© Copyright 2025. All Rights Reserved by MedPath