Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid

Launched by HEARX SA · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new type of hearing aid that you can fit yourself at home works compared to traditional hearing aids that are fitted by a professional. The goal is to see if these over-the-counter (OTC) hearing aids can help people with mild to moderate hearing loss just as much as prescription hearing aids do. The study will involve three phases: first, checking how accurate a simple hearing test is; second, gathering feedback from users about their experience; and third, comparing the self-fitting OTC hearing aid with a professionally fitted one in a controlled setting.

To participate in the trial, you need to be at least 18 years old and have mild to moderate hearing loss in both ears. Your ears also need to be healthy with no infections or blockages. Additionally, you should have access to a smartphone that can use the Lexie App, which is necessary for this study. If you qualify and choose to participate, you'll help researchers understand how these new hearing aids can improve hearing for many people who currently find it difficult to get the help they need.

Gender

ALL

Eligibility criteria

• 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)