Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sonova AG
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 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
Outcomes
Primary Outcomes
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
Time Frame: Three weeks
The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). 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 Outcomes
- Speech intelligibility in percent in a quiet listening situation(One week)
- Zero-defect performance in daily life(Three weeks)