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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing aid: Phonak Audéo B90-Direct
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Audéo B-Direct fitted with fitting method A

Audéo B-Direct fitted with fitting method B

Arm Description

Traditional standard fitting method which do not include adjustments from the participants.

Alternative fitting method which includes additional adjustments from the participants.

Outcomes

Primary Outcome Measures

Comparison of fitting method A versus B in regard to sound quality
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

Comparison of fitting method A versus B in regard to speech intelligibility in noise
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).

Full Information

First Posted
September 28, 2018
Last Updated
May 7, 2019
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT03755453
Brief Title
Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34
Official Title
Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Audéo B-Direct fitted with fitting method A
Arm Type
Active Comparator
Arm Description
Traditional standard fitting method which do not include adjustments from the participants.
Arm Title
Audéo B-Direct fitted with fitting method B
Arm Type
Experimental
Arm Description
Alternative fitting method which includes additional adjustments from the participants.
Intervention Type
Device
Intervention Name(s)
Hearing aid: Phonak Audéo B90-Direct
Intervention Description
Hearing aids will be fitted to the participants individual hearing loss.
Primary Outcome Measure Information:
Title
Comparison of fitting method A versus B in regard to sound quality
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Comparison of fitting method A versus B in regard to speech intelligibility in noise
Description
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).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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