Clinical trial NCT03992989: Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Sensorineural Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 pre-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 one CE-labeled Phonak Behind-the-ear (BTE) devices is investigated including CE-labeled compatible accessories. The experimental device will be investigated regarding its performance of speech understanding in noise with and without an accessory existing of an external microphone to pick sound at a certain target. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality. Another objective of this study is the investigation of the subjective occlusion effect of different acoustic couplings. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: 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
* Informed Consent as documented by signature
* owning a compatible smartphone
* Hearing loss in range of N2-N3 (ISO 60118-15)

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

Primary outcomes:
measure: Speech intelligibility in noise
timeFrame: 1 week
Secondary outcomes:
measure: Subjective Sound quality perception
timeFrame: 4 weeks
Other outcomes:
measure: Subjective occlusion effect
timeFrame: 4 weeks
measure: Sound quality for streamed audio signals
timeFrame: 1 week
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References: