Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort & performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.

Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Hearing Aid without NR enabled; Device: Hearing Aid with NR(1); Device: Hearing Aid with NR(2); Device: Hearing Aid with NR(3)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Stäfa, Switzerland, 8712
    • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature
• Minimum 1 year hearing aid experience
• Moderate-Severe (N3-N5) hearing loss or Normal Hearing

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
• Inability to produce a reliable hearing test result
• Massively limited dexterity
• Known psychological problems
• Known central hearing disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hearing Aid without NR(0) enabled; Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.	Device: Hearing Aid without NR enabled; Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
EXPERIMENTAL: Hearing Aid with NR (1); Hearing Aid with Noise Reduction I (NR) enabled.	Device: Hearing Aid with NR(1); Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
EXPERIMENTAL: Hearing Aid with NR(2); Hearing Aid with Noise Reduction II (NR) enabled.	Device: Hearing Aid with NR(2); Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
EXPERIMENTAL: Hearing Aid with NR(3); Hearing Aid with Noise Reduction III (NR) enabled.	Device: Hearing Aid with NR(3); Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Event-related-skin-conductance	Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes & latencies (micro-Siemens & milliseconds).	6 weeks
Differences in Event-related-pupil-dilation (ERPDs)	Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations. We use the unit: pixels. The size of a pixel in 1mm^2 is relative to the distance between the eye and the camera. Even though participants heads were placed on a chin rest that was always the same distance from the camera, the distance between the individual eye and the camera can still be different due to differences in participants' anatomies. Thus, pupil dilation are often reported relative to an individuals' baseline, for example as percent change relative to the baseline. Therefore, we use the unit: pixels, as the use of mm^2 may be inaccurate.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oldenburg Sentence Test	Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.	6 weeks
Sound Quality Ratings	The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as secondary outcome measure, are collected in the laboratory. The scale ranges from 0 "very bad" to 6 "very good" in increments of 1. Individual sound quality rating from participants are averaged over 3 different acoustic scenes for each hearing aid program.	6 weeks
Spectro-temporal-modulation Detection Thresholds (STM)	Stimuli which contain simultaneous frequency and amplitude modulations of a wide-band noise carrier are presented to the participants. The depth of the modulations is systematically varied and the individual modulation detection thresholds are recorded as a broadband decibel (dB) value. For each participant 4 measures were made and averaged to give a mean STM threshold.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-verbal Trail Making Test A & B	The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible according to a given order. In version A the order is given by increasing digit number (i.e. 1-25) while in version B the order is given by alternating digits and letters (i.e. 1-A-2-B-3-C…). The data, serving as an outcome measure, are time-to-complete the set in seconds.	2 weeks
Digit-Span Test Forward (FW) & Backward (BW)	The digit-span task is used to measure working memory's number storage capacity. Participants will see a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered, which means that the participant recalls two sequences out of a maximum of three sequences correct. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sentence in normal or reverse order.	2 weeks
Go/No-go Task	The Go/No-go task measures inhibitory control. Participants are asked to respond to a Go stimulus as fast as possible but not respond to a No-go stimulus. Go stimuli are presented at a rate much higher than the No-go stimuli to elicit prepotent motor activity. The outcome measure of this task is the number of commission errors (i.e. responding to a No-go stimuli) a participant commits as a measure of their ability to stop prepotent motor activity.	6 weeks
Blood Volume Pulse	Blood volume pulse will be recorded from participants during the performance of the auditory task (non-invasively with a photoplethysmographic (PPG) sensor). Analyses will be carried out on the data recorded during a time window following each auditory stimulus (relative to baseline activity). It is planned to analyze event-related changes in pulse rate and amplitude (beats per minute).	6 weeks
Respiration Data	Respiration rates will be recorded from participants during the auditory task using a belt placed under the ribcage. This data will only be used to control for changes in breathing patterns which may influence skin conductance measurements.	6 weeks
Skin Temperature Data	Skin temperature will be recorded from participants during the auditory task using a small thermometer attached to the outside of the little finger (non-dominant hand). This data will only be used to control for changes in temperature which may influence skin conductance measurements.	6 weeks
Acoustic Reflex Thresholds	Tympanometry will be used to assess the mobility of the eardrum, prior to recording Acoustic Reflex Thresholds (ARTs). Compliance [ml], Middle Ear Pressure [daPa] and ear canal volume [ml] will be recorded and checked that they fall within normal limits. Where this is the case, ARTs will be measured using 0.5, 1 & 2 kHz stimulus tones ipsi- and contralaterally for each ear. The resulting outcome measure will be the threshold [dB] required at each frequency and ear arrangement for a stapedial reflex to be present.	3 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2020
• Primary Completion (ACTUAL): March 2, 2021
• Study Completion (ACTUAL): April 22, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Sonova2020_09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No