Hearing Loss Clinical Trial
Official title:
Quality Control of CE-Certified Phonak Hearing Aids - 2018_28
Verified date | December 2019 |
Source | Sonova AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Status | Completed |
Enrollment | 28 |
Est. completion date | December 23, 2018 |
Est. primary completion date | November 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience - Good written and spoken (Swiss) German language skills - Healthy outer ear - Ability to fill in a questionnaire (p/eCRF) conscientiously - willingness to wear Receiver in the canal hearing aids - Informed Consent as documented by signature - owning a compatible smartphone 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 in Stäfa (Switzerland) - Limited ability to describe listening impressions/experiences and the use of the hearing aid - Inability to produce a reliable hearing test result - Known psychological problems - Central hearing disorders |
Country | Name | City | State |
---|---|---|---|
Switzerland | Sonova AG | Stäfa | Zürich |
Lead Sponsor | Collaborator |
---|---|
Sonova AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of Speech intelligibility in noise | Another Outcome measure of this study is the Evaluation of speech understanding in noise of the experimental device and the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the Signal-to-noise ration (SNR) in dB. | 10 weeks | |
Other | Evaluation of Speech intelligibility in quiet | Another Outcome measure of this study is the Evaluation of speech understanding in quiet of the experimental device and the active comparator. Speech understanding in quiet will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in % at certain Levels of loudness. | 10 weeks | |
Other | Evaluation of the Bluetooth stability (experimental device only) | Another outcome measure of this study is the investigation of bluetooth stability of the experimental device in terms of connection losses and interruptions. The bluetooth stability will be measured via interview and questionnaires during and after a home trial for the experimental device only. The active comparator device does not have Bluetooth Technology. | 10 weeks | |
Other | Evaluation of Usability preferences (experimental device only) | Another Outcome measure is the qualitative rating of user preferences when using direct connectivity Technology in Terms of streaming an audio signal from an external device with Bluetooth Technology to the experimental device. The user preferences will investigated via rating scales client on a questionnaire during a home trial period | 10 weeks | |
Primary | Evaluation of subjective acceptance of the default Hearing aid setting | The Primary Outcome measure of this study is the comparison of the default Hearing aid Fitting (first fit) in regard of the subjective acceptance rating between the experimental device and the active comparator (non-inferiority test design). The first fit acceptance will be measured via subjective satisfaction rating of different dimensions concerning sound quality perception and loudness perception (Scale of satisfaction rating ranging from 0% to 100%). | 10 weeks | |
Secondary | Subjective Sound Quality rating of streamed telephone call (experimental device only) | The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the streamed telephone signal, which will be streamed between a smartphone and the experimental device. | 10 weeks |
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