Hearing
Conditions
Brief 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.
Interventions
DEVICEApple Software
Amplification settings established by algorithm and further adjusted by participants per their preference
DEVICEby Audiologist
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
Sponsors
Iqvia Pty Ltd
Apple Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from multiple sites where audiological services were provided.
Pre-assignment details
All 118 enrolled participants were randomized into the study
Participants by arm
| Arm | Count |
|---|---|
| Self-Fit Settings Amplification settings established by algorithm and further adjusted by participants per their preference
Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference | 59 |
| Pro-Fit Settings Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice | 59 |
| Total | 118 |
Baseline characteristics
| Characteristic | Self-Fit Settings | Total | Pro-Fit Settings |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 50 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 68 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 116 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Four-Frequency Pure Tone Average Results-Full Analysis Set 15-25 dB HL (No Impairment) | 12 Participants | 27 Participants | 15 Participants |
| Four-Frequency Pure Tone Average Results-Full Analysis Set 26-40 dB HL (Mild Impairment) | 26 Participants | 52 Participants | 26 Participants |
| Four-Frequency Pure Tone Average Results-Full Analysis Set 41-60 dB HL (Moderate Impairment) | 21 Participants | 39 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 101 Participants | 48 Participants |
| Region of Enrollment United States | 59 Participants | 118 Participants | 59 Participants |
| Sex: Female, Male Female | 30 Participants | 69 Participants | 39 Participants |
| Sex: Female, Male Male | 29 Participants | 49 Participants | 20 Participants |
| Subject Medical History with >10.0% Occurrence Deafness bilateral | 26 Participants | 49 Participants | 23 Participants |
| Subject Medical History with >10.0% Occurrence Hypertension | 10 Participants | 22 Participants | 12 Participants |
| Subject Medical History with >10.0% Occurrence Hypoacusis | 5 Participants | 11 Participants | 6 Participants |
| Subject Medical History with >10.0% Occurrence Tinnitus | 14 Participants | 18 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 1 / 59 |
Outcome results
Primary
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.
Time frame: Approximately 18-31 days upon enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Fit Settings | International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results | 25.5 score on a scale | Standard Deviation 3.03 |
| Pro-Fit Settings | International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results | 26.6 score on a scale | Standard Deviation 3.63 |