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Quality Control of CE-Certified Phonak Hearing Aids - 2016_05

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02951247
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Sonova AG

Brief Summary:
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Hearing Aid Not Applicable

Detailed Description:
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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Quality Control of CE-Certified Phonak Hearing Aids
Actual Study Start Date : November 8, 2016
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : February 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids


Intervention Details:
  • Device: Hearing Aid
    Successor of Phonak Virto V90-10 NW O


Primary Outcome Measures :
  1. Zero-defect performance in daily life [ Time Frame: Four weeks ]
    The data, serving as primary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.


Secondary Outcome Measures :
  1. Speech intelligibility in noise as signal to noise ration in dB (dB SNR) [ Time Frame: Two weeks ]
    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 Oldenburger sentence test. The result is the signal to noise ratio in dB (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.

  2. Visibility [ Time Frame: Four weeks ]
    The data, serving as secondary outcomes are collected in a series of lab appointments. The visibility will be assessed with the aid of subjective questionnaires.

  3. Wearing Comfort [ Time Frame: Four weeks ]
    The data, serving as secondary outcomes are collected in a series of lab appointments. The wearing comfort will be assessed with the aid of subjective questionnaires.


Other Outcome Measures:
  1. Initial first fit acceptance (pre-calculation) in lab [ Time Frame: Two weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • Massively limited dexterity
  • Known psychological problems
  • Central hearing disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951247


Locations
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Switzerland
Sonova AG
Stafa, Zürich, Switzerland, 8712
Sponsors and Collaborators
Sonova AG

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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT02951247     History of Changes
Other Study ID Numbers: Sonova2016_05
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms