NCT03498274

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

March 19, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

February 28, 2018

Last Update Submit

January 22, 2019

Conditions

Hearing Loss

Keywords

Fitting

Outcome Measures

Primary Outcomes (1)

  • Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)

    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 Outcomes (2)

  • Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.

    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 to assess change is one month after the hearing aids have been worn with both fitting methods.

Other Outcomes (1)

  • Assessment of unexpected device behavior (ie. distortion) with a questionnaire

    Time frame to assess change is one month with the first measure after two weeks and the second week 3-4

Study Arms (2)

Fitting System

EXPERIMENTAL

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

Traditional Fitting System

ACTIVE COMPARATOR

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

Interventions

Fitting SystemDEVICE

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.

Fitting System
Traditional Fitting SystemDEVICE

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.

Traditional Fitting System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Audika

Thun, Canton of Bern, 3600, Switzerland

Location

Audika

Bern, 3011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 12467365BACKGROUND

MeSH Terms

Conditions

Hearing LossEpilepsy

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Barbara Simon

    Employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

April 13, 2018

Study Start

March 19, 2018

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)