Use of Airpod Pros as Assistive Technology

NCT06840015 | Recruiting FDA Device

• 1 other identifier: IRB-25-148
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the suitability and effectiveness of the AirPod Pro 2nd and 3rd generation (AP) as hearing assistive technology for individuals with mild-to-moderate hearing loss when listening in noisy environments. Researchers will compare four types of assistive technology: hearing aids (HAs), AP, dedicated wireless remote microphones, and Smartphone wireless remote microphone. The main questions it aims to answer are:

• Which assistive technology provides the greatest benefit for speech recognition in noisy environments?
• How do these devices impact listening effort, as measured by reaction time in a dual-task activity and changes in pupil size?
• What are participants' preferences for each device based on how easy it is to understand speech and their overall satisfaction? Participants will visit the lab for a single 3-hour session. They will listen to sentences using each device and repeat what they hear. During this task, their reaction times for the secondary task and changes in pupil size will be measured.

Conditions

Hearing Loss, Adult-Onset; Hearing Aids

Keywords

AirPod Pro (AP); Hearing Aids; Hearing Loss

Outcome Measures

Primary Outcomes (4)

• Speech recognition threshold at 70.7%

  Speech recognition threshold (SRT) at 70.7% is the noise level at which a person can correctly repeat 70.7% of sentences. Determine the appropriate dB SNR to measure sentence recognition with assistive technologies. It is measured in decibels (dB). Lower values indicate better performance.

  The measurement will be conducted immediately following the intervention within the 2-hour single session.

• Reponse time of secondary working memory task

  It refers to the amount of time it takes for a participant to react to and complete the secondary working memory task, performed alongside the primary task (speech recognition). This measurement reflects the participant's cognitive processing speed and listening effort. It is measured in seconds (s). Faster values indicate better performance.

  The measurement will be conducted immediately following the intervention within the 2-hour single session.

• Pupil diameter

  Pupil diameter reflects the motivation to exert effort through physiological mechanisms that maintain homeostasis, making it a reliable indicator of listening effort. It is measured in millimeters (mm). Larger pupil diameters typically indicates greater exerted effort.

  The measurement will be conducted immediately following the intervention within the 2-hour single session.

• Questionnaire

  Participants are asked to rate how easy it was to understand the speaker with each device. This scale ranges from "Very easy", "Easy", "Ok", "Hard", to "Very hard". They are also asked to select their most preferred device.

  The measurement will be conducted immediately following the intervention within the 2-hour single session.

Study Arms (1)

Treatment group

EXPERIMENTAL

AP, HA, ... (Randomized)

Device: Airpod Pro as hearing assistive technology

Interventions

Airpod Pro as hearing assistive technology DEVICE

All participants will use and evaluate four types of assistive technology: hearing aids, Airpod pro 2nd and 3rd generation, dedicated wireless remote microphones, and Smartphone wireless remote microphone.

Treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 years.
• Native English speakers.
• Mild-to-moderate hearing loss confirmed by a pure-tone hearing test (average hearing threshold screening 25 to 55 dB HL across octave frequencies from 250 to 8000 Hz).
• Individuals with no prior hearing aid experience for a year.

You may not qualify if:

• Normal hearing.
• Hearing loss worse than moderate.
• Neurological, psychiatric, or ophthalmological conditions that might alter the pupil response.
• Non-native English speakers.
• Individuals with prior hearing aid experience more than a year.

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

Callier Center for Communication Disorders

Richardson, Texas, 75080, United States

RECRUITING

Related Publications (3)

• Levitt H. Transformed up-down methods in psychoacoustics. J Acoust Soc Am. 1971 Feb;49(2):Suppl 2:467+. No abstract available.

  PMID: 5541744 BACKGROUND

• Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am. 1994 Feb;95(2):1085-99. doi: 10.1121/1.408469.

  PMID: 8132902 BACKGROUND

• Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

  PMID: 21829134 BACKGROUND

Related Links

• Platform to Assist in the Execution of Dual Task Tests

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda Thibodeau, Ph.D.

  The University of Texas at Dallas

  STUDY DIRECTOR

• Seeon Kim, Ph.D.

  Callier Center for Communication Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Thibodeau, Ph.D.

CONTACT

972-883-3108; thib@utdallas.edu

Seeon Kim, Ph.D.

CONTACT

4806164403; Seeon.Kim@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: February 21, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)