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

May 7, 2019 updated by: Sonova AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zürich
      • Stäfa, Zürich, Switzerland, 8712
        • Sonova AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 11, 2018

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (ACTUAL)

November 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonova2018_34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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