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Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

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ClinicalTrials.gov Identifier: NCT03131557
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : August 17, 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 usability, 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: Line extension of the Phonak Audéo B product family Device: Phonak Audéo B 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 Audéo B and a line extension of the Phonak Audéo B hearing aid product family 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 - 2017_13
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Line extension of the Phonak Audéo B hearing aid
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Device: Line extension of the Phonak Audéo B product family
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Active Comparator: Phonak Audéo B hearing aid
Phonak Audéo B will be fitted to the participants individual hearing loss.
Device: Phonak Audéo B
Phonak Audéo B will be fitted to the participants individual hearing loss.




Primary Outcome Measures :
  1. Usability (phone calls) [ Time Frame: One week ]
    The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. 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. 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.

  2. Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) [ 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 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.



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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): NCT03131557


Locations
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Switzerland
Sonova AG
Stafa, Zürich, Switzerland, 8712
Sponsors and Collaborators
Sonova AG
Investigators
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Principal Investigator: Simone Ebbing, B.Sc. Sonova AG

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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT03131557     History of Changes
Other Study ID Numbers: Sonova2017_13
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

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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