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Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

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ClinicalTrials.gov Identifier: NCT03108768
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : June 16, 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 participants with a hearing loss 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, Bilateral Sensorineural, Progressive Device: Hearing Aid (Successor of Phonak Virto V) Device: Hearing Aid (Phonak Virto V) 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 : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Successor of Phonak Virto V
The successor of Phonak's Virto V will be fitted to the participants individual hearing loss.
Device: Hearing Aid (Successor of Phonak Virto V)
The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.

Active Comparator: Phonak Virto V
Phonak Virto V will be fitted to the participants individual hearing loss.
Device: Hearing Aid (Phonak Virto V)
Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.




Primary Outcome Measures :
  1. Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) [ Time Frame: Three weeks ]
    The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg 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.


Secondary Outcome Measures :
  1. Speech intelligibility in percent in a quiet listening situation [ Time Frame: One week ]
    The data, serving as secondary 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.

  2. Zero-defect performance in daily life [ Time Frame: Three weeks ]
    The data, serving as secondary 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.



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Ages Eligible for Study:   18 Years to 99 Years   (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): NCT03108768


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: NCT03108768     History of Changes
Other Study ID Numbers: Sonova2016_37
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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