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

January 22, 2019 updated by: Bernafon AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3011
        • AUDIKA
    • Bern
      • Thun, Bern, Switzerland, 3600
        • AUDIKA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Fitting System
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.
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.
ACTIVE_COMPARATOR: Traditional Fitting System
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
Time Frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
The answers to the questionnaire will be compared for each fitting method to determine if the subjective hearing aid benefit is as good when using the IMD as with the RMD. There is no numerical outcome.
Time frame to assess change is one month with the first measure after two weeks and the second week 3-4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.
Time Frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
A standardized speech test will be given after each field test to compare the two fitting methods. Percentage of correct words repeated from both fitting methods will be compared to determine whether one method helped the subjects to achieve higher speech scores.
Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Assessment of hearing aid preference with a questionnaire
Time Frame: Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.
To assess if the subjects prefer one hearing aid over the other they will complete a preference questionnaire that asks specifically which hearing aid they preferred and why. There is no point scale just a selection of Hearing aid 1 or hearing aid 2.
Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of unexpected device behavior (ie. distortion) with a questionnaire
Time Frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
To assess the system for any unexpected behaviors and to evaluate any new risk factors to ensure safety of the devices, a questionnaire that distinctly asks questions about the occurence of unexpected noises such as excessive feedback or distortion will be given to the subjects. The questionnaire is based on a 5-point scale to quantify the rate of occurrence (with 1 being never to 5 being often).
Time frame to assess change is one month with the first measure after two weeks and the second week 3-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bernafon AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara Simon, Employee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BF002-1707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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