Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICECompetitor device, hearing aid with standard gain precalculation principle
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.
DEVICEHearing aid with gain precalculation principle 1
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
DEVICEHearing aid with gain precalculation principle 2
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
Sponsors
Sebastian Griepentrog
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Each participant will be treated with each gain precalculation principle in a randomized order
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility | From enrollment to the end of treatment at 3 weeks | Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative ratings on naturalness | From enrollment to the end of treatment at 3 weeks | Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition |
| Qualitative ratings on loudness | From enrollment to the end of treatment at 3 weeks | Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition |
| Qualitative ratings on own voice quality | From enrollment to the end of treatment at 3 weeks | Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORJosephine Hollenbach
Sonova AG
Outcome results
None listed