NCT04496271

Quality Control of CE-Certified Phonak Hearing Aids - 2020_06

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Phonak Hearing Devices pass through different development and study phases. 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, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved 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).

Detailed description

This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	RIC (Receiver in channel)- device	HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-03-16
• Completion: 2020-04-08
• First posted: 2020-08-03
• Last updated: 2022-11-28

Locations

1 site across 1 country: Switzerland