NCT03555084

Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Extension of Virto B-Titanium	In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
DEVICE	Virto B-Titanium	In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.

Timeline

• Start date: 2018-05-22
• Primary completion: 2018-06-22
• Completion: 2018-06-22
• First posted: 2018-06-13
• Last updated: 2018-09-17

Locations

1 site across 1 country: Switzerland