Hearing Loss
Conditions
Brief summary
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
Interventions
DEVICEHearing Aid (Phonak Audéo V90-13)
Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
DEVICEHearing Aid (Successor of Phonak Audéo V90-13)
The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * Good written and spoken (Swiss) German language skills * Healthy outer ear * Ability to fill in a questionnaire (p/eCRF) 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 * Central hearing disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility in percent in a quiet listening situation | One week | The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the german rhyme test Einsilber-Reimtest nach von Wallenberg und Kollmeier (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility in percent in a noisy listening situation | One week | The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german rhyme test Einsilber-Reimtest nach von Wallenberg und Kollmeier (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Initial first fit acceptance (pre-calulation) in lab | One week | The data, serving other pre-specified outcomes are collected within the first lab appointment. The acceptance of the initial first fit will be assessed with the aid of quantitative questions within an interview. The results are points on a scale and open ended (e.g. Question: Please rate the sound quality; Answer scale: bad, poor, fair, good, excellent) . Descriptive statistics will be executed in the form of determining number of answers. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued. |
| Sound quality and listening effort ratings in lab | Four weeks | The data, serving other pre-specified outcomes are collected within the lab appointments. The sound quality and listening effort ratings will be assessed with the aid of the Multi-Stimulus Test with Hidden Reference and Anchor (MUSHRA). The results are quantitative sound quality and listening effort ratings. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued. |
Countries
Switzerland
Outcome results
None listed