Status:
COMPLETED
Clinical Validation of the Lexie Lumen Hearing Aid
Lead Sponsor:
hearX Group
Collaborating Sponsors:
University of Pretoria
Conditions:
Hearing Loss
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation. The majority of people with h...
Detailed Description
Objective: To examine the difference in outcomes (satisfaction and objective benefit) of the Lexie self-test and self-fitting (Lexie- STF) hearing aid versus a Lexie hearing aid fitted professionally ...
Eligibility Criteria
Inclusion
- Adults aged between the ages of 18 to 99 years, living in South Africa.
- Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)
- Must have a self-perceived hearing loss
- Mild to severe sensorineural hearing loss (thresholds \<= 80 dB HL across frequencies bilaterally)
- Possession of a smartphone compatible with the Lexie app (iOS or Android)
- Access to mobile data to operate the Lexie app.
- Willingness and availability to participate in the study over a period of 45 days
Exclusion
- Normal hearing or profound hearing loss
- Active outer or middle ear disease
- Poor English proficiency
- Diagnosed cognitive impairment
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05337748
Start Date
April 11 2022
End Date
October 1 2022
Last Update
March 20 2025
Active Locations (1)
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1
University of Pretoria
Pretoria, Gauteng, South Africa, 0001