Smartphone Enabled Hearing Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apple Inc.
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
时间窗: 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.
次要结局
未报告次要终点