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Completed

NCT Number: NCT02740023

Quality Control of CE-Certified Phonak Hearing Aids - 2015_03

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.

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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 of Zurich, 8712, 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) with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • Informed Consent as documented by signature

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
  • 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

Hearing Aid (Phonak Audéo V90-13)

Device

Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

Hearing Aid (Successor of Phonak Audéo V90-13)

Device

The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

Primary outcomes

  1. Speech intelligibility in percent in a quiet listening situation

    Time frame: One week

    The data, serving as primary outcomes 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.

Secondary outcomes

  1. Speech intelligibility in percent in a noisy listening situation

    Time frame: One week

    The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise 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.

Other outcomes

  1. Initial first fit acceptance (pre-calulation) in lab

    Time frame: One week

    The data, serving other pre-specified outcomes are collected within the first lab appointment. The acceptance of the initial first fit will be assessed with the aid of quantitative questions within an interview. The results are points on a scale and open ended (e.g. Question: Please rate the sound quality; Answer scale: bad, poor, fair, good, excellent) . Descriptive statistics will be executed in the form of determining number of answers. 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. Sound quality and listening effort ratings in lab

    Time frame: Four weeks

    The data, serving other pre-specified outcomes are collected within the lab appointments. The sound quality and listening effort ratings will be assessed with the aid of the Multi-Stimulus Test with Hidden Reference and Anchor (MUSHRA). The results are quantitative sound quality and listening effort ratings. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

Quality Control of CE-Certified Phonak Hearing Aids

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Jun 21, 2018

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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