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

Sonova AG24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hearing Loss

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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).