Hearing Loss, Adult-OnsetNCT06840015
Use of Airpod Pros as Assistive Technology
A study testing Airpod Pro as hearing assistive technology in people with Hearing Loss, Adult-Onset and Hearing Aids, run by The University of Texas at Dallas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Adult-Onset, Hearing Aids
- What is being tested?
- Airpod Pro as hearing assistive technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 60 years.
- Fluent 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.
Who cannot join
- Normal hearing.
- Hearing loss worse than moderate.
- Neurological, psychiatric, or ophthalmological conditions that might alter the pupil response.
- Non-fluent English speakers.
- Individuals with prior hearing aid experience more than a year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Callier Center for Communication Disorders
Richardson, Texas, 75080
Kim, Ph.D., 480-616-4403, Seeon.Kim@utdallas.edu
Linda Thibodeau, Ph.D.
About this study
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.
Read the detailed description
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.
- Conditions
- Hearing Loss, Adult-Onset, Hearing Aids
- Being tested
- Airpod Pro as hearing assistive technology
- Keywords
- AirPod Pro (AP), Hearing Aids, Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airpod Pro as hearing assistive technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | AP, HA, ... (Randomized) Receives: Device: Airpod Pro as hearing assistive technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The measurement will be conducted immediately following the intervention within the 2-hour single session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jul 2025
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Adult-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Linda Thibodeau, The University of Texas at Dallas
- Investigators
- Linda Thibodeau, Ph.D., Study director, The University of Texas at DallasSeeon Kim, Ph.D., Principal investigator, Callier Center for Communication Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840015
- Sponsor's protocol ID
- IRB-25-148
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Don't have plan to share IPD.
Publications
Levitt H. Transformed up-down methods in psychoacoustics. J Acoust Soc Am. 1971 Feb;49(2):Suppl 2:467+. No abstract available.
PubMed 5541744Nilsson 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.
PubMed 8132902Spahr 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.
PubMed 21829134
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Airpod Pros as Assistive Technology
- ClinicalTrials.gov ID
- NCT06840015
- Acronym / sponsor ID
- IRB-25-148
- Conditions
- Hearing Loss, Adult-Onset, Hearing Aids
- Keywords
- AirPod Pro (AP), Hearing Aids, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Airpod Pro as hearing assistive technologyAP, HA, ... (Randomized) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 60 years.
- Fluent 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.
Key exclusion criteria (5 listed)
- Normal hearing.
- Hearing loss worse than moderate.
- Neurological, psychiatric, or ophthalmological conditions that might alter the pupil response.
- Non-fluent English speakers.
- Individuals with prior hearing aid experience more than a year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airpod Pro as hearing assistive technologyAll 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. | Device | Treatment group |
Primary outcome
Speech recognition threshold at 70.7%
Time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
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.
Reponse time of secondary working memory task
Time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
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.
Pupil diameter
Time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
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.
Questionnaire
Time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 5541744Levitt H. Transformed up-down methods in psychoacoustics. J Acoust Soc Am. 1971 Feb;49(2):Suppl 2:467+. No abstract available.
- Background: PubMed 8132902Nilsson 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.
- Background: PubMed 21829134Spahr 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.
- Platform to Assist in the Execution of Dual Task TestsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Don't have plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Thibodeau, Ph.D. study director
The University of Texas at Dallas
Seeon Kim, Ph.D. principal investigator
Callier Center for Communication Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airpod Pro as hearing assistive technology in people with Hearing Loss, Adult-Onset and Hearing Aids, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Thibodeau, Ph.D. (972-883-3108, thib@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recognition threshold at 70.7% (time frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840015, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.