Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid

Launched by HEARX SA · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new over-the-counter hearing aid called the Lexie B3 Pro, which is designed to help people with mild to moderate hearing loss. The goal is to see how well this hearing aid works compared to another similar device already available on the market. Researchers will look at how satisfied users are with both devices and how much they help improve hearing. This trial is part of a larger study to make hearing aids more accessible and user-friendly for people who may have difficulty getting traditional hearing aids due to costs or access.

To participate in this trial, individuals must be at least 18 years old and have mild to moderate hearing loss in both ears. They should also have a compatible smartphone to use with the Lexie App. However, those with severe hearing loss or certain ear conditions, like infections or significant earwax buildup, won't be eligible. Participants can expect to try out the Lexie B3 Pro hearing aid and share their experiences to help researchers understand its benefits and user experience. This study aims to make hearing aids easier for everyone to use and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)