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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04180254
Enrollment
45
Registered
2019-11-27
Start date
2019-11-18
Completion date
2020-01-31
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ability, Spatial

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.

Interventions

PROCEDUREEffect of several processing on the auditory distance perception

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

Sponsors

Swiss Commission for Technology and Innovation
CollaboratorOTHER
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

a group of normal hearing and hearing-impaired participants

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of the distance discrimination8 weeksParticipants 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026