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Speech Locator In-car Performance Evaluation

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Investigational adaptive directional microphone strategy
Comparator omnidirectional microphone strategy
Comparator fixed directional microphone strategy
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:

  • Adults (18-99 years) with ≥3 months hearing aid experience
  • binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
  • fluent in English

Exclusion Criteria:

  • children/teenagers
  • normal hearing or hearing loss exceeding N5 (severe) by 10 dB

Sites / Locations

  • Sonova Innovation Centre Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Investigational adaptive directional microphone strategy

Comparator omnidirectional microphone strategy

Comparator fixed directional microphone strategy

Arm Description

Receiver-in-canal hearing aid with an investigational adaptive directional microphone strategy.

Receiver-in-canal hearing aid with a comparator omnidirectional microphone strategy.

Receiver-in-canal hearing aid with a comparator fixed directional microphone strategy.

Outcomes

Primary Outcome Measures

Sound quality rating
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Dimensions rated are: Speech clarity: Very unclear, Unclear, Slightly clear, Clear, Very clear Noise annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying Spatialization: I don't know where the talker is, the talker might be [at location], The talker is probably [at location], The talker is [at location], The talker is definitely [at location] Overall impression: Bad, Poor, Fair, Good, Excellet Transition annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
April 8, 2022
Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05054816
Brief Title
Speech Locator In-car Performance Evaluation
Official Title
Speech Locator In-car Performance Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.

4. Oversight

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

5. Study Description

Brief Summary
Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational adaptive directional microphone strategy
Arm Type
Experimental
Arm Description
Receiver-in-canal hearing aid with an investigational adaptive directional microphone strategy.
Arm Title
Comparator omnidirectional microphone strategy
Arm Type
Active Comparator
Arm Description
Receiver-in-canal hearing aid with a comparator omnidirectional microphone strategy.
Arm Title
Comparator fixed directional microphone strategy
Arm Type
Active Comparator
Arm Description
Receiver-in-canal hearing aid with a comparator fixed directional microphone strategy.
Intervention Type
Device
Intervention Name(s)
Investigational adaptive directional microphone strategy
Intervention Description
A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Intervention Type
Device
Intervention Name(s)
Comparator omnidirectional microphone strategy
Intervention Description
A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Intervention Type
Device
Intervention Name(s)
Comparator fixed directional microphone strategy
Intervention Description
A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Primary Outcome Measure Information:
Title
Sound quality rating
Description
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Dimensions rated are: Speech clarity: Very unclear, Unclear, Slightly clear, Clear, Very clear Noise annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying Spatialization: I don't know where the talker is, the talker might be [at location], The talker is probably [at location], The talker is [at location], The talker is definitely [at location] Overall impression: Bad, Poor, Fair, Good, Excellet Transition annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying
Time Frame
Up to 6 hours over 3 2-hour sessions

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: Adults (18-99 years) with ≥3 months hearing aid experience binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss fluent in English Exclusion Criteria: children/teenagers normal hearing or hearing loss exceeding N5 (severe) by 10 dB
Facility Information:
Facility Name
Sonova Innovation Centre Toronto
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L1J3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Speech Locator In-car Performance Evaluation

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