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Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34

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ClinicalTrials.gov Identifier: NCT03755453
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sonova AG

Study Description
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Brief Summary:
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Hearing aid: Phonak Audéo B90-Direct Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
Actual Study Start Date : October 11, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 28, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Audéo B-Direct fitted with fitting method A
Traditional standard fitting method which do not include adjustments from the participants.
 Device: Hearing aid: Phonak Audéo B90-Direct
Hearing aids will be fitted to the participants individual hearing loss.
Experimental: Audéo B-Direct fitted with fitting method B
Alternative fitting method which includes additional adjustments from the participants.
 Device: Hearing aid: Phonak Audéo B90-Direct
Hearing aids will be fitted to the participants individual hearing loss.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of fitting method A versus B in regard to sound quality [ Time Frame: 2 months ]
    The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.


Secondary Outcome Measures :
  1. Comparison of fitting method A versus B in regard to speech intelligibility in noise [ Time Frame: 2 months ]
    The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT).


Eligibility Criteria
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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

Participants fulfilling all of the following inclusion criteria are eligible for the study:

  • Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

  • 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 appointments
  • Limited ability to describe listening impressions or to use hearing aids/ accessories
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders
Contacts and Locations
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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): NCT03755453


Locations
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Switzerland
Sonova AG
Stäfa, Zürich, Switzerland, 8712
Sponsors and Collaborators
Sonova AG
More Information
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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT03755453    
Other Study ID Numbers: Sonova2018_34
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
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 Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases