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Completed

NCT Number: NCT02754843

Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

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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, Canton Zürich, 8635, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hearing impaired persons with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

Exclusion criteria

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

Treatment and study plan

Phonak's equivalent newly developped power BTE

Device

Equivalent competitor device

Device

Primary outcomes

  1. Speech intelligibility in quiet. Discrimination [%]

    Time frame: One week.

    The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the German rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. 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.

  2. Speech intelligibility in noise. Speech Reception Threshold [dB SNR]

    Time frame: One week.

    The data, serving as primary outcome, 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 Speech Reception Threshold [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.

Secondary outcomes

  1. Phoneme Perception Test, test no. 1.

    Time frame: Four weeks

    Free field audiometry using narrow band high frequency signals to measure detection thresholds [dB]. 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.

  2. Phoneme Perception Test, test no. 2.

    Time frame: Four weeks

    Free field audiometry using high frequency phonemes to capture their recognition thresholds [dB]. 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.

  3. Phoneme Perception Test, test no. 3.

    Time frame: Four weeks

    Free field audiometry using high frequency phonemes to capture the subjects' distinction capabilities [confusion matrix]. 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.

  4. Diary to describe hearing impressions in everyday life

    Time frame: Six weeks

    Subjects are asked to describe their subjective experiences in different listening situations, in daily life, with the aid of quantitative questionnaires. the results are "Yes/No" replies and open-ended.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 28, 2016
Registry last updated
Apr 28, 2016

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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