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Completed

NCT Number: NCT04187781

Quality Control of CE-Certified Phonak Hearing Aids - 2019_34

Phonak Hearing Devices pass through different development and study phases. 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, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved 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 Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, 8712, Switzerland

About this study

This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.

The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).

The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.

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

  • experienced hearing aid user
  • severe hearing loss
  • willingness and interest in testing an external microphone healthy outer ear
  • willingness to wear behind the ear hearing aids
  • Informed Consent as documented by signature

Exclusion criteria

  • the audiogram is not in the fitting range of the intended hearing aid
  • limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
  • participant is not able to describe experiences and hearing impressions

Treatment and study plan

external microphone

Device

External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

Primary outcomes

  1. Rating of the subjective comfort for the old and the new setting

    Time frame: 6 weeks

    Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)

Secondary outcomes

  1. Evaluation of the speech intelligibility in noise

    Time frame: 2 weeks

    Another Outcome measure of this study is the Evaluation of speech understanding in noise of the device with the old setting and the new setting. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in %.

  2. Subjective Sound Quality rating

    Time frame: 6 weeks

    The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the signal with the old setting, compared to the new setting of the external microphone.

  3. Subjective rating of natural sounds

    Time frame: 6 weeks

    The subject should rate in the hometrial how natural environmental sounds are with the hearing aids.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Mar 3, 2020

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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