HearingNCT05872035
Smartphone Enabled Hearing Study
A study testing Apple Software and by Audiologist in people with Hearing, run by Apple Inc. at 1 site in United States.
Trial summary
Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing
- What is being tested?
- Apple Software and by Audiologist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 17 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Proficient in written and spoken English, defined by self-report
- Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)
- Participants have access to stable internet connection
Who cannot join
- Ear anatomy non-conducive to comfortable wear of headphone
- Active ear disease
- Cerumen impaction that cannot be removed
- Sudden loss of hearing (in the preceding 90 days), defined by self-report
- Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1
- Tinnitus that impacts one's daily life, defined by self-report
Show all 16Show fewer
- Use of cochlear implants
- Self-reported issues with small or confined spaces such as a single-person enclosed booth, and/or claustrophobia
- Health technology, fitness, media outlet employees (or spouse of employees), or employees of CRO/sites contracted to execute this study
- User noted preference to not wear headphone consistently, or charge headphone and smartphone consistently, during field-use
- Hearing loss >60 dB HL at 0.25-3kHz and >65 dB HL at 4kHz in either ear; assessed during PTA
- Hearing loss that requires electroacoustic settings which are not acoustically stable in the participant's ear per audiologist judgement
- Current regular use of hearing aids
- Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
- Active treatment, or treatment in the past 6 months, with parenteral aminoglycoside antibiotics
- In the Investigator's opinion, unable to adhere to study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.
- Conditions
- Hearing
- Being tested
- Apple Software, by Audiologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple SoftwareDevice
Amplification settings established by algorithm and further adjusted by participants per their preference
by AudiologistDevice
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
| Study group | Role | What they receive |
|---|---|---|
| Self-Fit Settings | Experimental | Amplification settings established by algorithm and further adjusted by participants per their preference Receives: Device: Apple Software |
| Pro-Fit Settings | Active comparator | Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice Receives: Device: by Audiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.
Measured: Approximately 18-31 days upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start20 Apr 2023
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HearingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apple Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872035
- Sponsor's protocol ID
- 099-37012
- Status last verified
- Oct 2024
- First submitted
- 26 Apr 2023
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Enabled Hearing Study
- ClinicalTrials.gov ID
- NCT05872035
- Acronym / sponsor ID
- 099-37012
- Conditions
- Hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Apple Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Fit Settings | Experimental | Device: Apple SoftwareAmplification settings established by algorithm and further adjusted by participants per their preference |
| Pro-Fit Settings | Active comparator | Device: by AudiologistAmplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Proficient in written and spoken English, defined by self-report
- Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)
- Participants have access to stable internet connection
Key exclusion criteria (16 listed)
- Ear anatomy non-conducive to comfortable wear of headphone
- Active ear disease
- Cerumen impaction that cannot be removed
- Sudden loss of hearing (in the preceding 90 days), defined by self-report
- Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1
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 |
|---|---|---|
| Apple SoftwareAmplification settings established by algorithm and further adjusted by participants per their preference | Device | Self-Fit Settings |
| by AudiologistAmplification settings established by clinical reference and further adjusted by an audiologist per current best practice | Device | Pro-Fit Settings |
Primary outcome
International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
Time frame: Approximately 18-31 days upon enrollment
The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Software and by Audiologist in people with Hearing, run by Apple Inc. 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 16 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results (time frame: Approximately 18-31 days upon enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2024.