Skip to main content
OpenTrials
Completed

NCT Number: NCT03938753

Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

About this study

In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The experimental device will be investigated regarding Sound Quality perception ot the T-Coil program. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated within this study. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss)
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • Willingness to wear Receiver in the canal hearing aids
  • Informed Consent as documented by signature
  • Owning a compatible smartphone

Exclusion criteria

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Known psychological problems
  • Central hearing disorders

Treatment and study plan

Audéo M90-T

Device

Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.

Primary outcomes

  1. Subjective perception of the T-Coil Sound Quality

    Time frame: 4 weeks

    The primary objective of this study is to measure that the overall sound Quality of the T-Coil program [subjective satisfaction rating on a scale from 0%-100% in 1% steps] of the investigational device is rated as at least as 60% or better [60% is the border between 'ok' and 'satisfied'] after a test period with daily life situations.

Secondary outcomes

  1. Program switch-back workflow into T-Coil program

    Time frame: 4 weeks

    The number of incorrect switch-back occurences will be measured under laboratory conditions. A switch-back workflow is defined as the correct (re)activation of the T-Coil program, after an automatic program change into a streaming program. Due to an incoming phone call or due a start of audio streaming via Bluetooth, the investigational device will automatically switch into a streaming program. As soon as the Bluetooth stream stops, the investigation device must automatically toggle back into the T-Coil program (switch-back workflow).

Other outcomes

  1. Observation of the system stability

    Time frame: 4 weeks

    Another objective of this study is the monitoring of the system stability during daily life situations. The investigational device will be worn for 4 weeks in home trial. Each investigational device will track the system stability in the background (unnoticeable for the HI-wearer). A log file of the system stability can be read out by the investigator. The system stability will be calculated by the amount of tracked system artefacts in relation to the overall wearing time. System artefacts are not or only hardly noticeable for the HI wearer, so that these system artefacts can only be tracked by reading out the data logging of the investigational device.

  2. Sound Quality rating of T-Coil program under lab conditions

    Time frame: 4 weeks

    Another objective is the subjective perception of the Sound Quality of the T-Coil under laboratory condition. Subjects will rate the perceived Sound Quality of an audio file streamed via T-Coil on a scale from 'not at all' to 'excellent'.

  3. Subjective perception of audio artefacts in T-Coil program

    Time frame: 4 weeks

    Another objective is to count the number of reports from subjects regarding audible artefacts in the T-Coil program after a home trial phase of 4 weeks. Audible artefacts are defined as any disturbing unnatural sounds which interfere with a streamed signal via T-Coil. Artefacts will be noted on a client questionnaire.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 6, 2019
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.