Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software

Phonak

Status: Completed

Conditions: Validation Studies

Treatments: Device: Real-Ear Measurement system integrated in hearing aid fitting software

Study type: Interventional

Funder types: Industry

Identifiers

NCT02555462

KEK-ZH-NR.2015-0099

Details and patient eligibility

About

Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.

Enrollment: 205 estimated patients

Sex: All

Ages: 16 to 67 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clean and healthy ear canal, eardrum and pinna
• Ability to keep current position (of head and body) during a period of about 5 minutes while seated.

Exclusion criteria

• Ear infections
• Ear wax in the ear
• Hyperacusis
• Pacemaker
• Tremor
• Disability to keep position.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Real-Ear Measurement

Experimental group

Description:

The study arm goes through a comparative test run followed by a comparative hearing aid fitting.

Treatment:

Device: Real-Ear Measurement system integrated in hearing aid fitting software