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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03514758
Enrollment
20
Registered
2018-05-02
Start date
2018-03-26
Completion date
2018-05-31
Last updated
2018-12-06

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

The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.

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 volunteers

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Head movements measured with head tracker6 weeksThe 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 \[s\].

Countries

Switzerland

Outcome results

None listed

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