Hearing Screener Study

NCT ID: NCT05848804

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-12-31

Brief Summary

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The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter

Detailed Description

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Conditions

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Hearing Screener

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linus Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce Gomes-Osman, PhD

Role: STUDY_DIRECTOR

Linus Health

Locations

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Crossover Mangement

Wake Forest, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William I Morrow

Role: CONTACT

9196141515

Russell Banks, PhD

Role: CONTACT

Facility Contacts

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David Woolever

Role: primary

Other Identifiers

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HSCS-001

Identifier Type: -

Identifier Source: org_study_id

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