An interventional study of Airpod Pro as hearing assistive technology in Hearing Loss, Adult-Onset and Hearing Aids, sponsored by The University of Texas at Dallas. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
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:
A total of 24 participants will be recruited from the Callier Center, local audiology offices, support groups, and senior centers and will first undergo a pure-tone hearing test in a sound booth. The preferred ear tip for the Airpod Pro 3rd generation (AP) will be selected based on participant's comfort, ensuring it passes the ear tip fit test in the iPhone operating system. Similarly, the appropriate ear tip for the receiver-in-the canal Phonak Paradise hearing aid will be selected. The devices will be fit bilaterally and programmed for the individual's hearing loss using the smartphone or computer. Real-ear measurements will be then conducted with both the HAs and the APs to verify that their amplification reaches the The National Acoustic Laboratories non-linear version 2 (NAL-NL2) target level bilaterally (± 5 decibels) for the individual's degree of hearing loss, using Audioscan Verifit 2 (version 4.26.3).
The speech recognition threshold (SRT) at 70.7% will first be measured using the AP and a 2-down-1-up adaptive procedure, adjusting the signal-to-noise ratio (SNR) of babble noise using Hearing in Noise Test (HINT). The sentence will be presented at 65 dBA constant level from Knowles Electronics Manikin for Acoustic Research (KEMAR) with a mouth simulator positioned 1 meter at 0 degrees azimuth. The noise will be presented from the two speakers positioned 1 meter at 90- and 270-degrees azimuth. The participant must repeat the key words correctly. The SNR step size will initially be set to 4 dB for the first three reversals to enable rapid convergence, then reduced to 2 dB to refine the threshold measurement. This procedure will continue until six to eight reversals are obtained to ensure threshold stability. This approach will provide a reliable measurement of the SRT with the AP and allow enough range for improvements to comparison with other assistive technologies.
Next, the participants will complete a dual-task paradigm at the SNR that resulted in 70.7% performance with AP, both without assistive technology and with technology including HA, AP, dedicated wireless remote microphones (DRM), or Smartphone wireless remote microphone (SRM). The target speech will be presented through KEMAR with a mouth simulator positioned 1 meter at 0 degrees azimuth, with babble noise from two speakers positioned 1 meter at 90- and 270-degrees azimuth. The primary task will involve sentence recognition in babble noise using different AzBio sentence lists mentioned above. The secondary task will utilize a working memory task from PALETA (www.paleta.fob.usp.br). While listening to and repeating the AzBio sentence aloud, participants will simultaneously look at the screen, memorize, and click the sequence of colors. Listening effort will be measured by calculating the difference in response time (RT) for the secondary task between the dual-task condition (primary and secondary) and single-task (secondary only) condition.
Following this, the pupil diameter will be measured while participants repeat sentences presented, serving as an additional measure to more reliably assess listening effort under consistent same speaker, SRT and device settings. The AzBio sentence list (Spahr et al., 2012), consisting of 20 sentences, will be used with each assistive technology condition, totaling five sets. Pupil diameter will be captured using the Tobii Pro Lab Analyzer software (version 1.217, Tobii Technology AB, Stockholm, Sweden) positioned 1 meter in front of the participant. This measure will provide two key insights: listening effort and speech recognition ability. We will then compare listening effort and speech recognition with and without each assistive device to determine which assistive technology provides the greatest benefit for speech recognition and listening effort in noisy environments.
Finally, participants will complete a questionnaire to evaluate their experience with each assistive technology. During the pupillometry session, they will rate the difficulty of the sentence recognition task immediately after using each device. At the end of the session, participants will select their preferred assistive technology with the reason for their choice.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 24 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
AP, HA, ... (Randomized)
Device: Airpod Pro as hearing assistive technology
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
Plan to share: No — Don't have plan to share IPD.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 17 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
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