Trial Outcomes & Findings for fNIRS, Listening Effort, and Motivation (NCT NCT05893992)

NCT ID: NCT05893992

Last Updated: 2025-08-17

Results Overview

Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Session 1, 2, 3 and 4; assessed for up to 2 hours
• Results posted on: 2025-08-17

Participant Flow

Participant milestones

Measure	Digital Noise Management, Then Quiet Listening Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments.	Quiet Listening, Then Digital Noise Management Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hearing Loss n=26 Participants All participants will have hearing loss and be assigned to all two interventions. The interventions consist of calm-situation listening and noise management feature. Hearing aids with noise management features for listening in noise: Device for hearing loss compensation with digital noise management features Hearing aid for listening in quiet environments: Device for hearing loss compensation for listening in quiet environments
Age, Categorical <=18 years	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=26 Participants
Age, Categorical >=65 years	18 Participants n=26 Participants
Age, Continuous	69 years STANDARD_DEVIATION 7.1 • n=26 Participants
Sex: Female, Male Female	12 Participants n=26 Participants
Sex: Female, Male Male	14 Participants n=26 Participants
Region of Enrollment Canada	26 Participants n=26 Participants

PRIMARY outcome

Timeframe: Session 1, 2, 3 and 4; assessed for up to 2 hours

Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.

Outcome measures

Measure	Participants With Hearing Loss n=26 Participants Participants with hearing loss who are candidates for hearing aids
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) Hearing aid with noise management	-14.85 Oxygenation (uMol) Standard Error 4.65
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) Hearing aids for quiet listening	4.15 Oxygenation (uMol) Standard Error 4.65

SECONDARY outcome

Timeframe: Session 1, 2, 3 and 4; assessed for up to 2 hours

Speech understanding in noise percent correct scores

Outcome measures

Measure	Participants With Hearing Loss n=26 Participants Participants with hearing loss who are candidates for hearing aids
Listening Accuracy Hearing aids with noise management	75.8 Percentage of words repeated correctly Standard Deviation 15.2
Listening Accuracy Hearing aids for quiet listening	62.3 Percentage of words repeated correctly Standard Deviation 19.4

SECONDARY outcome

Timeframe: Session 1, 2, 3 and 4; assessed for up to 2 hours

Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required.

Outcome measures

Measure	Participants With Hearing Loss n=26 Participants Participants with hearing loss who are candidates for hearing aids
Subjective Listening Effort Rating Hearing aids with noise management	3.08 units on a scale Standard Deviation 0.960
Subjective Listening Effort Rating Hearing aids for quiet listening	4.08 units on a scale Standard Deviation 0.892

Adverse Events

Hearing Loss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Vaisberg

Sonova

Phone: 9057456785

Email: jonathan.vaisberg@sonova.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place