Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
- Conditions
- Hearing Loss, Sensorineural
- Interventions
- Device: Virto B-TitaniumDevice: Extension of Virto B-Titanium
- Registration Number
- NCT03555084
- Lead Sponsor
- Sonova AG
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Adult hearing impaired persons (minimum age: 18 years) with or 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
- willingness to wear custom made Hearing aids
- Informed Consent as documented by signature
- Benefit with TFG tool at least on one ear
- 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
- Limited dexterity (not able to change a 10size Hearing aid battery)
- no Benefit of the TFG tool on both ears
- Known psychological problems
- Central hearing disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Device: Phonak Virto B-Titanium Virto B-Titanium The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss. Device: Extension of Phonak Virto B-Titanium Extension of Virto B-Titanium The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
- Primary Outcome Measures
Name Time Method Visibility and Wearing Comfort 3 weeks The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
- Secondary Outcome Measures
Name Time Method Measurement of acoustic Feedback Thresholds 3 weeks Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain \[in dB SPL\] of at least 20 dB in a specific frequency range.
Trial Locations
- Locations (1)
Sonova AG
🇨🇭Stäfa, Zürich, Switzerland