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

NCT04167735 | Completed

• 1 other identifier: Sonova2019_33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oldenburg sentence test

  4 weeks

• subjective rating

  4 weeks

Other Outcomes (1)

• Non-verbal Trail Making Test A & B

  1 week

Study Arms (2)

Hearing Aid without Reverberation Canceller (no_RevC)

ACTIVE COMPARATOR

Hearing Aid without Reverberation Canceller (RevC)

Device: Hearing Aid without Reverberation Canceller (RevC).

: Hearing Aid Reverberation Canceller enabled (RevC_1)

EXPERIMENTAL

Hearing Aid Reverberation Canceller enabled (RevC\_1)

Device: Hearing Aid Reverberation Canceller enabled (RevC_1)

Interventions

Hearing Aid without Reverberation Canceller (RevC). DEVICE

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.

Hearing Aid without Reverberation Canceller (no_RevC)

Hearing Aid Reverberation Canceller enabled (RevC_1) DEVICE

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.

: Hearing Aid Reverberation Canceller enabled (RevC_1)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

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: November 15, 2019
• First Posted: November 19, 2019
• Study Start: October 22, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)