Speech Locator In-car Performance Evaluation

Hearing Loss Clinical Trial

Official title:

Speech Locator In-car Performance Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054816
• Other study ID #: SRF-459
• Status: Completed
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: March 11, 2022

Study information

• Verified date: September 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Investigational adaptive directional microphone strategy
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.
• Comparator omnidirectional microphone strategy
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.
• Comparator fixed directional microphone strategy
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.

Locations

Country	Name	City	State
Canada	Sonova Innovation Centre Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Sonova Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 hours over 3 2-hour sessions