Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2018
CompletedFirst Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedSeptember 18, 2018
September 1, 2018
2 months
June 20, 2018
September 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Electroencephalogram (EEG) data
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.
8 weeks
Secondary Outcomes (1)
Subjective Listening Effort rating
8 weeks
Study Arms (3)
Hearing Aid without NR and BF
ACTIVE COMPARATORHearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
Hearing Aid with NR
EXPERIMENTALHearing Aid with Noise Reduction (NR) enabled.
Hearing Aid with BF
EXPERIMENTALHearing Aid with beam forming (BF) enabled.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, 8712, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliane Raether
Sonova AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 6, 2018
Study Start
June 4, 2018
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
September 18, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share