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Recruiting Not applicable NCT07388784

Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility

No applicable phase (e.g. observational)
Conditions: Hearing Loss

Sponsor: Sebastian Griepentrog

trial.available_in: БГ
Overview
An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.
Who can participate
Inclusion Criteria: * Hearing impaired adult at a minimum age of 18 years * Good written and spoken german skills * Ability to fill in a questionnaire concientiously * Ability to produce a reliable hearing test result * Ability to describe listening impressions / experiences * Audiogram is in the fitting range of the hearing aids Exclusion Criteria: * Unaidable hearing loss in one or both ears * Auricle deformities that prevent secure placement of the investigational device * Acute tinnitus in one or both ears * Unwillingness to test the investigational device * Asymmetrical hearing loss * Hypersensitivity or allergy against synthetic materials * Symptoms of vertigo or dizziness * Suffering from any otologic disease
Interventions
Competitor device, hearing aid with standard gain precalculation principle
DEVICE
Hearing aid with gain precalculation principle 1
DEVICE
Hearing aid with gain precalculation principle 2
DEVICE
Locations 1
Switzerland (1)
Sonova AG
Stäfa
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
20.04.2026
Completion date
30.05.2026
Registry ID
NCT07388784
Source
clinicaltrials.gov
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