Clinical trial NCT03498274: A Comparison of a Currently Marketed Hearing Aid Programmed With Two Different Fitting Methods
Official title: A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Keywords: Fitting
Lead sponsor: Bernafon AG
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a controlled, randomized, cross-over, open label, comparative clinical investigation. A randomized cross-over design is used with half of the test subjects wearing the device fit with the traditional fitting method first and the other half using the self-directed method and then switching after approximately 10 +/-5 days.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
timeFrame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Secondary outcomes:
measure: Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.
timeFrame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
measure: Assessment of hearing aid preference with a questionnaire
timeFrame: Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.
Other outcomes:
measure: Assessment of unexpected device behavior (ie. distortion) with a questionnaire
timeFrame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Locations:
city: Thun
country: Switzerland
facility: Audika
state: Bern
city: Bern
country: Switzerland
facility: Audika
Study officials:
affiliation: Employee
name: Barbara Simon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available.