Comparing a new hearing screener to traditional methods
Linus Health Hearing Screening Clinical Study
This study is testing a new hearing screener to see if it works as well as traditional methods for people aged 55 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Linus Health, Inc. Industry-sponsored |
| Locations | 1 site (Wake Forest, North Carolina) |
| Trial ID | NCT05848804 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the Linus Health Hearing Screener (LHHS) by comparing its results to those obtained from established hearing screening methods conducted by hearing specialists. Participants aged 55 and older will undergo a speech hearing test in an office setting, with measurements taken from an iPad at a distance of one foot. The study will assess the accuracy of the LHHS in identifying hearing thresholds against traditional methods. The goal is to determine if the LHHS can provide reliable hearing assessments in a more accessible format.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 and older with varying degrees of hearing ability who can use an iPad and are fluent in English.
Not a fit: Patients who are deaf, have major psychiatric issues, or significant medical problems like cancer or epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more convenient and effective method for hearing screening, improving access to hearing assessments for older adults.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel assessment method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English. Exclusion Criteria: * Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.
Where this trial is running
Wake Forest, North Carolina
- Crossover Mangement — Wake Forest, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: William I Morrow
- Email: imorrow@linus.health
- Phone: 9196141515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.