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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing Aid without Reverberation Canceller (RevC).
Hearing Aid Reverberation Canceller enabled (RevC_1)
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hearing Aid without Reverberation Canceller (no_RevC)

: Hearing Aid Reverberation Canceller enabled (RevC_1)

Arm Description

Hearing Aid without Reverberation Canceller (RevC)

Hearing Aid Reverberation Canceller enabled (RevC_1)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oldenburg sentence test
1. Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
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.

Full Information

First Posted
November 15, 2019
Last Updated
December 13, 2019
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT04167735
Brief Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33
Official Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid without Reverberation Canceller (no_RevC)
Arm Type
Active Comparator
Arm Description
Hearing Aid without Reverberation Canceller (RevC)
Arm Title
: Hearing Aid Reverberation Canceller enabled (RevC_1)
Arm Type
Experimental
Arm Description
Hearing Aid Reverberation Canceller enabled (RevC_1)
Intervention Type
Device
Intervention Name(s)
Hearing Aid without Reverberation Canceller (RevC).
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid Reverberation Canceller enabled (RevC_1)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Event-related-pupil-dilations (ERPDs)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Oldenburg sentence test
Description
1. Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Time Frame
4 weeks
Title
subjective rating
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Non-verbal Trail Making Test A & B
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sonova AG
City
Stäfa
ZIP/Postal Code
8712
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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