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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2024-08-26

Brief Summary

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

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Detailed Description

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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).

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Evaluation of Study Device followed by Own devices

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.

Group Type EXPERIMENTAL

Hearing Aid Signia Pure C&G 7IX

Intervention Type DEVICE

Receiver in Canal (RIC) hearing aid, M Receiver

Own Hearing Aid

Intervention Type DEVICE

subjects' own hearing aids, any brand, any model

Interventions

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Hearing Aid Signia Pure C&G 7IX

Receiver in Canal (RIC) hearing aid, M Receiver

Intervention Type DEVICE

Own Hearing Aid

subjects' own hearing aids, any brand, any model

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No