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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16

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ClinicalTrials.gov Identifier: NCT03578471
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sonova AG

Study Description
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Brief Summary:
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Condition or disease Intervention/treatment Phase
Hearing Loss Normal Hearing Device: Hearing Aid without NR and BF Device: Hearing Aid with NR Device: Hearing Aid with BF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hearing Aid without NR and BF
Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
 Device: Hearing Aid without NR and BF
Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
Experimental: Hearing Aid with NR
Hearing Aid with Noise Reduction (NR) enabled.
 Device: Hearing Aid with NR
Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.
Experimental: Hearing Aid with BF
Hearing Aid with beam forming (BF) enabled.
 Device: Hearing Aid with BF
Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.


Outcome Measures
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Primary Outcome Measures :
  1. Electroencephalogram (EEG) data [ Time Frame: 8 weeks ]
    Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.


Secondary Outcome Measures :
  1. Subjective Listening Effort rating [ Time Frame: 8 weeks ]
    The subjective Listening Effort rating will be assessed through self-reported individual listening effort on a scale from "extreme effort" to "no effort".


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578471


Locations
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Switzerland
Sonova AG
Stäfa, Switzerland, 8712
Sponsors and Collaborators
Sonova AG
Investigators
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Principal Investigator: Juliane Raether Sonova AG
More Information
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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT03578471    
Other Study ID Numbers: Sonova2018_16
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases