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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755453
• Other study ID #: Sonova2018_34
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing aid: Phonak Audéo B90-Direct
Hearing aids will be fitted to the participants individual hearing loss.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Secondary	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).	2 months