A Comparison of a Currently Marketed Hearing Aid Programmed With Two Different Fitting Methods

Bernafon

Status: Terminated

Conditions: Hearing Loss

Treatments: Device: Fitting System; Device: Traditional Fitting System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03498274

BF002-1707

Details and patient eligibility

About

This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.

Full description

Benefits of amplification and accessories used with it outweigh anticipated risks in mild to profound hearing impaired subjects. The basic benefit of amplification should be present with any method that the trained professional fitting the instruments uses. The goal of this study is to compare two fitting methods and determine whether the end user perceives more benefit from one fitting method over the other. The objective benefit is expected to be the same; however, the subjective benefit may be different due to a possible psychological effect from more effort or time spent by the trained professional.

Bernafon will conduct this clinical investigation to test current hearing instruments fitted with the standard procedure and a self-directed procedure. Safety and performance validation of the new self-directed fitting software is needed before release to the market.

The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and determine whether different fitting methods provide the same perceived benefit. Additionally, this study will validate the safety of the fitting procedure as well as collect post market safety information about the devices themselves. The goal is to evaluate the audiological performance objectively as well as the subjective benefit. Furthermore, it is important to identify unexpected, unwanted behavior from the fitting software and the devices.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All types of hearing loss (sensorineural, conductive, mixed)
• If the hearing loss is conductive or mixed it must first be approved for amplification by a physician
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to severe
• First time hearing aid users (never worn hearing aids before)
• German speaking
• Both genders
• Ages 18 and older
• Ability and willingness to sign the consent form

Exclusion criteria

• Current hearing aids users
• Contraindications for amplification
• Active ear disease
• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
• A reduced mobility unable to attend weekly study appointments
• A reduced ability to describe auditory impressions and the usage of the hearing aids
• Uncooperative so that it is not possible to record a valid pure tone audiogram
• A strongly reduced dexterity
• With psychological problems
• Central hearing disorders
• Bernafon employees
• Family members of Bernafon employees

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Fitting System

Experimental group

Description:

a self-directed hearing screening based on a known algorithm from Audiology Inc. sold in an automated audiogram by Grason Stadler, GSI and a simplified version of the software. The flow of the new software is driven by the end user, but a trained professional should always assist with the fitting. The new software will first perform a hearing screening on the end user and then recommend a hearing aid and prescribe amplification to the hearing aid based on the hearing screening results.

Treatment:

Device: Fitting System

Traditional Fitting System

Active Comparator group

Description:

A traditional fitting method will be used as a control. This system is controlled by a trained professional, who performs the entire fitting without much interaction from the end user. The hearing instruments will be fit with the same settings as the experimental arm.

Treatment:

Device: Traditional Fitting System