Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.

The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Inclusion Criteria:

• all kinds of hearing loss (sensorineural, conductive, combined)
• all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
• mother tongue (swiss) german

Exclusion Criteria:

Subjects

• with a reduced mobility unable to attend weekly study appointments
• without access to a number of different hearing situations
• with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
• which are uncooperative so that it is not possible to record a valid pure tone audiogram
• with a strongly reduced dexterity
• with psychological problems
• central hearing disorders