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

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.

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Key information

Conditions

Ability, Spatial Behavior Spatial Behavior Spatial Navigation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effect of several processing on the auditory distance perception

Procedure

The focus is a comparison of hearing instrument algorithms on the auditory distance perception

Primary outcomes

Success rate of the distance discrimination

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

Swiss Commission for Technology and Innovation

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 27, 2019
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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