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

Not Applicable

Completed

• Conditions: Hearing Loss; Normal Hearing
• Interventions: Device: Hearing Aid with NR; Device: Hearing Aid without NR and BF; Device: Hearing Aid with BF

• Registration Number: NCT03578471
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Aid with NR	Hearing Aid with NR	Hearing Aid with Noise Reduction (NR) enabled.
Hearing Aid without NR and BF	Hearing Aid without NR and BF	Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
Hearing Aid with BF	Hearing Aid with BF	Hearing Aid with beam forming (BF) enabled.

Primary Outcome Measures

Name	Time	Method
Electroencephalogram (EEG) data	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

Name	Time	Method
Subjective Listening Effort rating	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".

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland