NCT03498274

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

A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bernafon AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Fitting System	End users will drive the screening and fitting flow; however, a trained professional is intended to assist them and help with explanations and the actual fitting of the hearing aids on the person. For a first time user the physical act of placing the hearing aid in/on the ear may create confusion. Therefore, the software is designed for an assistant to guide the user through the process and help with specific parts of the fitting or any questions in general.
DEVICE	Traditional Fitting System	The trained professional will fit the hearing aids with the traditional software that is currently used on the market. They will not involve the patient except to play demonstration tones.

Timeline

• Start date: 2018-03-19
• Primary completion: 2018-06-11
• Completion: 2018-06-11
• First posted: 2018-04-13
• Last updated: 2019-01-23

Locations

2 sites across 1 country: Switzerland