Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

A methodical evaluation of 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 sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements 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

Inclusion Criteria:

• Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
• Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Informed Consent as documented by signature
• Symmetric hearing loss below 1000 Hz

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 on study site
• Inability to produce a reliable hearing test result
• Known psychological problems
• Central hearing disorders