Clinical trial NCT03131557: Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Bilateral Sensorineural, Progressive
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2017-04-27
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: CROSSOVER
Intervention model description: Phonak Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Detailed description: 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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator 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) 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 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
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Usability (phone calls)
timeFrame: One week
Secondary outcomes:
measure: Zero-defect performance in daily life
timeFrame: Three weeks
measure: Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
timeFrame: One week
Other outcomes:
Locations:
city: Stafa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
affiliation: Sonova AG
name: Simone Ebbing, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References: