Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT05872035
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05872035
Study Brief:
Protocol Section:
NCT05872035