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

Sonova AG44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hearing Loss Normal Hearing

Interventions

Hearing Aid with NRDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

Subjective Listening Effort rating

The subjective Listening Effort rating will be assessed through self-reported individual listening effort on a scale from "extreme effort" to "no effort".