Open-source Hearing Aid Platform Comparisons

NCT05693610 | Terminated Results

• 1 other identifier: Pro00062688
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source speech platform (OSP) was developed to bridge the gap between audiology research and commercial hearing aid features, to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. All human subjects-related activities will be conducted at Northwestern University (single-site study).

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Keywords

Hearing aid; Hearing loss

Outcome Measures

Primary Outcomes (1)

• Word-identification Ability

  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.

  Post-intervention (1 day)

Secondary Outcomes (2)

• Phoneme Confusions

  Post-intervention (1 day)

• Response Time

  Post-intervention (1 day)

Study Arms (2)

Portable OSP

EXPERIMENTAL

Outcomes will be assessed with the portable version of the OSP.

Device: Portable OSP

Cloud-based OSP

EXPERIMENTAL

Outcomes will be assessed with the cloud-based version of the OSP.

Device: Cloud-based OSP

Interventions

Portable OSP DEVICE

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.

Portable OSP

Cloud-based OSP DEVICE

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.

Cloud-based OSP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years of age; any sex
• Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
• Speak English as their primary language
• Normal or corrected-to-normal vision
• Participants will be in good health (self-report)

You may not qualify if:

• Clinically significant unstable or progressive medical conditions
• Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment)
• Evidence of conductive hearing loss or middle ear issues
• Significant history of otologic or neurologic disorders
• Non English-speaking or non-native English speaking

Sponsors & Collaborators

• Northwestern University: lead
• Nadi LLC: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Varsha Rallapalli
• Organization: Northwestern University

varsha8904@gmail.com

847-467-0897

Study Officials

• Varsha H Rallapalli, AuD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since the portable and cloud-based versions of the device are visibly different, it is not possible to mask the participant.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Within-subjects design; Different levels of intervention outcomes are compared

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: January 23, 2023
• Study Start: January 6, 2023
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: January 10, 2025
• Results First Posted: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)