Status:
WITHDRAWN
Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid
Lead Sponsor:
HearX SA
Conditions:
Hearing Loss
Hearing Impairment
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and afford...
Detailed Description
Hearing loss is a prevalent condition affecting a significant portion of the global population, leading to challenges in communication, social interactions, and overall quality of life. Recent data in...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease (determined through otoscopic examination of the ear)
- 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 have Type A or As or Ad tympanogram as measured by tympanometry.
- Must be in possession of a smartphone compatible with the Lexie App (minimum iOS 13 or Android OS 10), preferably within equal distributio
- Exclusion Criteria:
- Younger than 18 years
- Presents with severe or greater hearing loss in either ear
- Presents with an 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 a smartphone, compatible with the Lexie App (minimum iOS 13 or Android OS 10)
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06942325
Start Date
September 1 2025
End Date
December 31 2025
Last Update
November 20 2025
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