N/A
Completed N=10
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Source: ClinicalTrials.gov NCT04723173 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Subjective Listening Effort Scaling — -2.276; -0.917 SNR (dB)
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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Listening Effort Scaling |
-2.276; -0.917 | — |
| SECONDARY Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) |
4; 4; 3.5; 4 | — |
| SECONDARY Measure of Detection Threshold (in dB) for Soft Sounds |
36.62; 38.21 | — |
| SECONDARY Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) |
2; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Adult hearing impaired persons (minimum age: 18 years, severe to profound Hearing loss)
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- willingness to wear Behind-the-ear hearing aids
- 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
- Known psychological problems
Data sourced from ClinicalTrials.gov (NCT04723173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.