MedTrace Logo

Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

NCT03992989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-30

No results posted yet for this study

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

Interventions

DEVICE

Phonak Bolero M90-M

The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss

DEVICE

Roger Select

The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

Sponsors & Collaborators

  • Sonova AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2019-07-06
Completion
2019-07-06

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992989 on ClinicalTrials.gov