Trial Outcomes & Findings for Open-source Hearing Aid Platform Comparisons (NCT NCT05693610)

Last Updated: 2025-01-10

Results Overview

Word identification ability will be assessed using the Modified Rhyme Test. Participants will select a word out of a choice of six rhyming words. The words may be in quiet or mixed with background noise and will be presented through headphones (for the intervention type: cloud-based OSP) or via loudspeakers (for the intervention type: portable OSP). Participants may be asked to record their responses on paper or via a button/mouse click on a computer or tablet screen. Scores will be based on the percentage of words identified correctly (range: 0-100%). A higher score indicates better word identification ability. The task is expected to take 30 minutes for each test condition.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Post-intervention (1 day)

Results posted on

2025-01-10

Participant Flow

This was a single arm, within-subjects study design and each participant completed both study interventions. First the portable OSP was tested followed by the cloud-based OSP for all participants.

Participant milestones

Participant milestones
Measure	Portable OSP, Then Cloud-based OSP Outcomes will be assessed with the portable and cloud-based versions of the OSP. Portable OSP: The portable open-source speech processing platform (OSP) is accessed on a browser via a wireless fidelity (WiFi)-enabled portable communication device that carries out all the signal processing. The processed sounds are transmitted to the ears via earpieces known as behind-the-ear receivers in the canal (same as those available with commercial hearing aids). The amount of amplification with the portable OSP will be customized for each listener based on a validated prescription. Cloud-based OSP: The cloud-based open-source speech processing platform (OSP) is hosted on a web-server which includes the software for all the signal processing. The processed sounds are transmitted to the ears via calibrated headphones. The amount of amplification with the cloud-based OSP will be customized for each listener based on a validated prescription.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-source Hearing Aid Platform Comparisons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Portable OSP, Then Cloud-based OSP n=11 Participants Outcomes will be assessed with the portable and cloud-based versions of the OSP. Portable OSP: The portable open-source speech processing platform (OSP) is accessed on a browser via a wireless fidelity (WiFi)-enabled portable communication device that carries out all the signal processing. The processed sounds are transmitted to the ears via earpieces known as behind-the-ear receivers in the canal (same as those available with commercial hearing aids). The amount of amplification with the portable OSP will be customized for each listener based on a validated prescription. Cloud-based OSP: The cloud-based open-source speech processing platform (OSP) is hosted on a web-server which includes the software for all the signal processing. The processed sounds are transmitted to the ears via calibrated headphones. The amount of amplification with the cloud-based OSP will be customized for each listener based on a validated prescription.
Age, Continuous	43 years STANDARD_DEVIATION 23.09 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-intervention (1 day)

Population: Includes individuals with normal hearing and hearing loss

Outcome measures

Outcome measures
Measure	Portable OSP n=11 Participants Outcomes will be assessed with the portable version of the OSP. Portable OSP: The portable open-source speech processing platform (OSP) is accessed on a browser via a wireless fidelity (WiFi)-enabled portable communication device that carries out all the signal processing. The processed sounds are transmitted to the ears via earpieces known as behind-the-ear receivers in the canal (same as those available with commercial hearing aids). The amount of amplification with the portable OSP will be customized for each listener based on a validated prescription.	Cloud-based OSP n=11 Participants Outcomes will be assessed with the cloud-based version of the OSP. Cloud-based OSP: The cloud-based open-source speech processing platform (OSP) is hosted on a web-server which includes the software for all the signal processing. The processed sounds are transmitted to the ears via calibrated headphones. The amount of amplification with the cloud-based OSP will be customized for each listener based on a validated prescription.
Word-identification Ability	78.12 percentage of words correct Interval 71.54 to 84.71	85.07 percentage of words correct Interval 80.77 to 89.36

SECONDARY outcome

Timeframe: Post-intervention (1 day)

Population: Due to errors in the software, this outcome measure was not collected for any of the participants.

Phoneme confusions will be obtained from the Modified Rhyme Test conducted in outcome measure 1. The phoneme confusions will be derived by comparing the selected words to the target word in the task and will be presented in terms of number or percentage of substitution, insertion, deletion errors. No addition task is required for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-intervention (1 day)

Population: Includes individuals with normal hearing and hearing loss.

Response time will be obtained from the Modified Rhyme Test conducted in outcome measure 1. Response time is a measure of time taken (in seconds) to identify a word correctly or incorrectly.

Outcome measures

Outcome measures
Measure	Portable OSP n=11 Participants Outcomes will be assessed with the portable version of the OSP. Portable OSP: The portable open-source speech processing platform (OSP) is accessed on a browser via a wireless fidelity (WiFi)-enabled portable communication device that carries out all the signal processing. The processed sounds are transmitted to the ears via earpieces known as behind-the-ear receivers in the canal (same as those available with commercial hearing aids). The amount of amplification with the portable OSP will be customized for each listener based on a validated prescription.	Cloud-based OSP n=10 Participants Outcomes will be assessed with the cloud-based version of the OSP. Cloud-based OSP: The cloud-based open-source speech processing platform (OSP) is hosted on a web-server which includes the software for all the signal processing. The processed sounds are transmitted to the ears via calibrated headphones. The amount of amplification with the cloud-based OSP will be customized for each listener based on a validated prescription.
Response Time	3.91 seconds Interval 3.51 to 4.3	3.60 seconds Interval 3.27 to 3.94

Adverse Events

Portable OSP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cloud-based OSP

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

Varsha Rallapalli

Northwestern University

Phone: 847-467-0897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place