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Quality Control of CE-Certified Phonak Hearing Aids - 2017_37

NCT03379766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-09

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 and functions. 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

DEVICE

Successor of Phonak Audéo B-Direct

The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.

DEVICE

Phonak Audéo B-Direct

The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Sponsors & Collaborators

  • Sonova AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-02-02
Completion
2018-02-02

Countries

  • Switzerland

Study Locations

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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 NCT03379766 on ClinicalTrials.gov