Clinical Trial: Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

Brief Summary: A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Detailed 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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Sponsor: Sonova AG

Current Primary Outcome: Usability (phone calls) [ Time Frame: One week ]

The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Zero-defect performance in daily life [ Time Frame: Three weeks ]
    The data, serving as primary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.
  • Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) [ Time Frame: One week ]
    The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburger sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.


Original Secondary Outcome: Same as current

Information By: Sonova AG

Dates:
Date Received: April 24, 2017
Date Started: June 12, 2017
Date Completion: July 7, 2017
Last Updated: April 24, 2017
Last Verified: April 2017