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Use of Frequency Compression in Severe-profound Hearing Loss Adults (FC)

Primary Purpose

Frequency Compression, Severe-profound Hearing Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aid feature: Frequency Compression
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frequency Compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants must be over 18 years of age- This study is looking at the use of frequency compression & its effects of speech perception in adults.
  2. No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables.
  3. No history of ear surgery within the last 12 months- To ensure limited confounding variables.
  4. No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing.
  5. No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing.
  6. Bilateral severe-profound hearing impairment with air conduction thresholds >71dBHL within the frequency range of 250Hz to 4 kHz- To analyse the effects of frequency compression on speech perception within this patient population.
  7. Post lingual deafness, with good spoken English- To ensure reliability of speech testing.
  8. Previous bilateral digital hearing aid experience (6+ months)- To ensure limited confounding variables.
  9. Written consent required.

Exclusion Criteria:

  1. Participants under the age of 18 years.
  2. History of ear surgery making it impossible to fit a hearing aid.
  3. History of ear surgery within the last 12 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Experimental

    Experimental

    Arm Label

    FC Deactivated

    FC activated & set to default

    FC activated and set to hearing loss

    Arm Description

    Frequency Compression feature on hearing aids is deactivated for 4 weeks

    Frequency compression feature activated on hearing aids and set to default software settings for 4 weeks.

    Frequency Compression feature activated on hearing aids and set to hearing loss cut-off for 4 weeks

    Outcomes

    Primary Outcome Measures

    CHEAR Auditory Perception Test
    Aided Monosyllabic Speech Test
    Adaptive Bamford-Kowal-Bench Test
    Aided Sentence Test

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2020
    Last Updated
    November 9, 2020
    Sponsor
    University College, London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04623112
    Brief Title
    Use of Frequency Compression in Severe-profound Hearing Loss Adults
    Acronym
    FC
    Official Title
    Do Severe-profound Hearing Impaired Adults Perform Better in Speech Perception With Frequency Compression Switched on or Off or Fitted to Hearing Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.
    Detailed Description
    Frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. It works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frequency Compression, Severe-profound Hearing Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FC Deactivated
    Arm Type
    Other
    Arm Description
    Frequency Compression feature on hearing aids is deactivated for 4 weeks
    Arm Title
    FC activated & set to default
    Arm Type
    Experimental
    Arm Description
    Frequency compression feature activated on hearing aids and set to default software settings for 4 weeks.
    Arm Title
    FC activated and set to hearing loss
    Arm Type
    Experimental
    Arm Description
    Frequency Compression feature activated on hearing aids and set to hearing loss cut-off for 4 weeks
    Intervention Type
    Device
    Intervention Name(s)
    Hearing aid feature: Frequency Compression
    Other Intervention Name(s)
    Non-linear Frequency Compression
    Intervention Description
    FC Deactivated/Activated & set to default/Activated & set to hearing loss
    Primary Outcome Measure Information:
    Title
    CHEAR Auditory Perception Test
    Description
    Aided Monosyllabic Speech Test
    Time Frame
    4 weeks post hearing aid fitting with adapted hearing aid feature
    Title
    Adaptive Bamford-Kowal-Bench Test
    Description
    Aided Sentence Test
    Time Frame
    4 weeks post hearing aid fitting with adapted hearing aid feature

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be over 18 years of age- This study is looking at the use of frequency compression & its effects of speech perception in adults. No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables. No history of ear surgery within the last 12 months- To ensure limited confounding variables. No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing. No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing. Bilateral severe-profound hearing impairment with air conduction thresholds >71dBHL within the frequency range of 250Hz to 4 kHz- To analyse the effects of frequency compression on speech perception within this patient population. Post lingual deafness, with good spoken English- To ensure reliability of speech testing. Previous bilateral digital hearing aid experience (6+ months)- To ensure limited confounding variables. Written consent required. Exclusion Criteria: Participants under the age of 18 years. History of ear surgery making it impossible to fit a hearing aid. History of ear surgery within the last 12 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah Vickers, Phd
    Organizational Affiliation
    UCL Ear Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Use of Frequency Compression in Severe-profound Hearing Loss Adults

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