Status:
WITHDRAWN
Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid
Lead Sponsor:
HearX SA
Conditions:
Hearing Loss
Self Perceived Hearing Loss
Eligibility:
All Genders
18-105 years
Phase:
NA
Brief Summary
Hearing loss significantly impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as acce...
Detailed Description
Hearing loss is a prevalent global health concern with significant social, emotional, and economic consequences. Sensorineural hearing loss (SNHL) is the most common type among adults, often resulting...
Eligibility Criteria
Inclusion
- The participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease.
- The participant must have bilateral self-perceived mild-moderate hearing loss.
- Baseline pure tone evaluations should fall within a 4-frequency PTA (0.5, 1.0, 2.0, 4.0 kHz) of 65 dB HL or less.
- The participant must have an adequate level of English proficiency as measured objectively using an English proficiency test (EF SET).
- The participant must present with Type A or As or Ad tympanogram as measured by tympanometry.
- Must be in possession of a smartphone compatible with the Lexie App (Android OS 8)
Exclusion
- Younger than 18 years
- Severe or greater hearing loss
- Outer or middle ear abnormality
- Have any of the following as per FDA (21 CFR 801.420) reg-flag conditions as contraindications to OTC hearing aid use :
- (i) Visible congenital or traumatic deformity of the ear preventing insertion of the receiver wire and dome into the ear.
- (ii) History of sudden active drainage (i.e. blood or pus) from the ear within the previous 6 months.
- (iii) Painful or uncomfortable feeling in your ear (iv) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
- (v) History of sudden or rapidly progressive hearing loss within the previous 6 months.
- (vi) Acute or chronic dizziness. (vii) Unilateral hearing loss. (viii) Fluctuating hearing loss (ix) Unilateral tinnitus
- Low English proficiency - \<51% of EF-SET
- No access or in possession of an Android smartphone, compatible with the Lexie App (minimum Android OS 8)
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06878300
Start Date
July 1 2025
End Date
August 31 2025
Last Update
November 20 2025
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