Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Sonova AG
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Sound quality ratings
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy outer ear (without previous surgical procedures)
- •Ability to fill in a questionnaire conscientiously
- •Informed Consent as documented by signature
Exclusion Criteria
- •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 weekly appointments
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •Inability to produce a reliable hearing test result
- •Massively limited dexterity
- •Known psychological problems
- •Known central hearing disorders
- •colour blinded
Outcomes
Primary Outcomes
Sound quality ratings
Time Frame: 4 weeks
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.
Secondary Outcomes
- Oldenburg sentence test in noise(4 weeks)
- Oldenburg sentence test & manual tracking task(4 weeks)
- Adaptive Categorial Listening Effort Scaling (ACALES)(2 weeks)
- Self-report form(One week)