Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO

Standard PMCF Study WSA @ HZO

The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities

This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).

Inclusion Criteria:

• Hearing loss should fall within fitting range of study hearing aid
• They should be experienced hearing aid users
• Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
• Sensorineural HL, mild-to-moderate
• HL corresponding to the fitting range of the hearing aid
• Healthy (outer) ear
• Older than 18 years
• German is mother tongue
• Able to understand the instructions
• Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
• Informed consent

Exclusion Criteria:

• Contraindication for hearing aid treatment
• Fluctuating or rapidly progressing hearing loss
• "Central" hearing problems
• Limited mobility
• Limited dexterity (in handling the hearing aid)
• Known psychological problems