Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33

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

Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. While listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. Participants are asked to repeat back the sentences loud. At fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. Two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. The same conditions will be re-tested once after a minimum of one day. A pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Hearing Aid without Reverberation Canceller (RevC).; Device: Hearing Aid Reverberation Canceller enabled (RevC_1)

• Study Type: Interventional
• Enrollment (Actual): 18
• 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
• Mild-Moderate/Severe (N2-N4) hearing loss

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hearing Aid without Reverberation Canceller (no_RevC); Hearing Aid without Reverberation Canceller (RevC)	Device: Hearing Aid without Reverberation Canceller (RevC).; Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is without Reverberation Canceller principle enabled.
Experimental: : Hearing Aid Reverberation Canceller enabled (RevC_1); Hearing Aid Reverberation Canceller enabled (RevC_1)	Device: Hearing Aid Reverberation Canceller enabled (RevC_1); Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The experimental condition applies the Reverberation Canceller and is predicted to provide a benefit in reverberant room simulations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Event-related-pupil-dilations (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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oldenburg sentence test	1. Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.	4 weeks
subjective rating	Subjective ratings: using a game controller, participants rate the difficulty of the sentences and listening effort on a visual analog scale. The scale is continuous and ranges from minimal to maximal difficulty/effort. The position of the cursor on the scale is then used to calculate a percentage from 0-100% difficulty/effort.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-verbal Trail Making Test A & B	The Trail Making Test 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 while still maintaining accuracy. The data, serving as an outcome measure, are time-to-complete the set in seconds	1 week

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

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: Sonova2019_33

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