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Completed

NCT Number: NCT03718975

Quality Control of CE-Certified Phonak Hearing Aids - 2018_28

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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

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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 a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and speech intelligibility in Quiet and in Noise. The experimental device contains direct connectivity functionality which will be investigated in terms of streamed Audio quality, streaming stability and Usability preferences of functions and Features which are related to direct connectivity. The active comparator device does not contain direct streaming functionality. This will be a clinical investigation 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, mild to moderate Hearing loss) without hearing aid experience
  • 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

Successor of Phonak Audéo B90

Device

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

Phonak Audéo B90

Device

The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.

Primary outcomes

  1. Evaluation of subjective acceptance of the default Hearing aid setting

    Time frame: 10 weeks

    The Primary Outcome measure of this study is the comparison of the default Hearing aid Fitting (first fit) in regard of the subjective acceptance rating between the experimental device and the active comparator (non-inferiority test design). The first fit acceptance will be measured via subjective satisfaction rating of different dimensions concerning sound quality perception and loudness perception (Scale of satisfaction rating ranging from 0% to 100%).

Secondary outcomes

  1. Subjective Sound Quality rating of streamed telephone call (experimental device only)

    Time frame: 10 weeks

    The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the streamed telephone signal, which will be streamed between a smartphone and the experimental device.

Other outcomes

  1. Evaluation of Speech intelligibility in noise

    Time frame: 10 weeks

    Another Outcome measure of this study is the Evaluation of speech understanding in noise of the experimental device and the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the Signal-to-noise ration (SNR) in dB.

  2. Evaluation of Speech intelligibility in quiet

    Time frame: 10 weeks

    Another Outcome measure of this study is the Evaluation of speech understanding in quiet of the experimental device and the active comparator. Speech understanding in quiet will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in % at certain Levels of loudness.

  3. Evaluation of the Bluetooth stability (experimental device only)

    Time frame: 10 weeks

    Another outcome measure of this study is the investigation of bluetooth stability of the experimental device in terms of connection losses and interruptions. The bluetooth stability will be measured via interview and questionnaires during and after a home trial for the experimental device only. The active comparator device does not have Bluetooth Technology.

  4. Evaluation of Usability preferences (experimental device only)

    Time frame: 10 weeks

    Another Outcome measure is the qualitative rating of user preferences when using direct connectivity Technology in Terms of streaming an audio signal from an external device with Bluetooth Technology to the experimental device. The user preferences will investigated via rating scales client on a questionnaire during a home trial period

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2018
Registry last updated
Dec 5, 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.

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