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

WS Audiology (WSAUD)

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: Own Hearing Aid; Device: Hearing Aid Signia Pure C&G 7IX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700512

D00325215

Details and patient eligibility

About

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

Full description

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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Evaluation of Study Device followed by Own devices

Experimental group

Description:

within subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care.

Treatment:

Device: Own Hearing Aid

Device: Hearing Aid Signia Pure C&G 7IX