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Completed

NCT Number: NCT04496791

Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

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 investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hearing Loss range: N3-N4
  • experienced hearing aid user
  • 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
  • first time user
  • limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
  • participant is not able to describe experiences and hearing impressions
  • allergies against the material of the hearing aid

Treatment and study plan

RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

Device

HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Primary outcomes

  1. Rating of the sound quality for the new and the comparative HI

    Time frame: 4 weeks

    Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)

Secondary outcomes

  1. Speech intelligibility in noisy situations (only test device)

    Time frame: 4 week

    Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR.

  2. Speech intelligibility in quiet situations

    Time frame: 4 week

    Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the "Reimtest nach Wallenberg und Kollmeier (WaKo ) (%).

  3. Speech intelligibility in noisy situations

    Time frame: 4 weeks

    Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score)

  4. Rating of sound quality

    Time frame: 1 week

    Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2020
Registry last updated
Sep 10, 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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