About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Competitor device, hearing aid with standard gain precalculation principle
- Hearing aid with gain precalculation principle 1
- Hearing aid with gain precalculation principle 2
Treatment groups
Sponsors and collaborators
Sebastian Griepentrog
Lead sponsor
Sonova AG
Sponsor institution