Hearing Loss, Sensorineural
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. 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 validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Detailed description
In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Interventions
DEVICEPhonak Audéo B90-Direct
The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
DEVICEHearingAid_A
HearingAid\_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_A which will be fitted to the participants individual Hearing loss.
DEVICEHearingAid_B
HearingAid\_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_B which 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)
Masking description
Participant masking was only done for laboratory measurements. For home trial testing no masking was done.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 an iPhone 6 or higher
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the speech intelligibiltity of phone calls via direct streaming | 6 weeks | The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid) | 6 weeks | The secondary outcome measurement of this study is to investigate the number of (Bluetooth-) Connection losses between Hearing Aid and Smartphone during a phone call stream. The bluetooth connection losses will be investigated by counting the reported interruptions of a streamed phone call between smartphone and Hearing Aid in relation to the amount of conducted phone calls during two weeks of home trial for the investigational device and the comparative devices. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity | 6 weeks | Another outcome measurement of this study is the comparison of streamed audio signals from TV in terms of sound quality (measured via satisfaction rating). |
| Comparison of the Usability of remote controls via direct connectivity | 6 weeks | Another outcome measurement of this study is the comparison of the usability of a remote control via interview during and after home trial. |
Countries
Switzerland
Outcome results
None listed