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

NCT06878300 | Withdrawn DMC

• 1 other identifier: LexieB3Pro
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 access and affordability limit their adoption, even in countries with developed audiological services . Despite their proven benefits, many individuals who could benefit from hearing aids do not obtain them. Traditionally, hearing aids required professional consultations, which created access challenges. In 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can provide similar benefits to professionally fitted ones in speech recognition and self-reported outcomes. One critique of past studies is that they often compare OTC hearing aids to audiologist-fitted devices using the same hardware, with differences primarily in programming methods. While much research has focused on fitting methods, this study aims to evaluate a new OTC hearing aid with its proprietary fitting algorithm against a marketed competitor. This randomized controlled trial (RCT) forms part of a larger validation study that follows a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer and Phase 2 assesses user experience. This RCT (Phase 3) will compare two OTC devices-the Lexie B3 Pro and a competitor already on the market-to evaluate self-reported benefit, user experience, and satisfaction. The hypothesis is that both devices provide comparable outcomes.

Conditions

Hearing Loss; Self Perceived Hearing Loss; Hearing Impairment

Keywords

over the counter hearing aids; self-fitting hearing aids; hearing aids

Outcome Measures

Primary Outcomes (1)

• Hearing aid perception questionnaire

  To achieve the study's primary objective of comparing the self-fitting Lexie B3 Pro OTC hearing aid device with the comparable market-available OTC self-fitting device, the primary outcome will be measured using a self-developed questionnaire with Likert scale questions. This questionnaire is designed to gather detailed insights into participants' perceptions of the devices' features and their experiences using both the self-fitting Lexie B3 Pro device and the market-available model after completing each field trial. No specific scoring is used as the study aims to obtain descriptive insights between the two devices.

  At the end of the two week field trial (with each device)

Study Arms (2)

OTC SF (Lexie)

EXPERIMENTAL

Participants in this group will be provided with a Lexie self-fitting OTC hearing aid that features a proprietary fitting algorithm designed to optimize amplification settings based on user input. Participants will independently set up and adjust the device without professional assistance, following the manufacturer's instructions, as would be the standard use case for self-fitting hearing aids. They will use the device for a two-week take-home field trial before crossing over to the alternative study arm.

Device: Over the counter hearing aid (Lexie)

OTC SF Competitor

EXPERIMENTAL

Participants in this group will receive a different self-fitting OTC hearing aid that utilizes its own manufacturer-specific fitting approach. As in the experimental arm, participants will complete the setup independently without professional guidance, adjusting the device based on the available self-fitting process. They will use this device for a two-week take-home field trial before switching to the experimental arm.

Device: Comparator over the counter hearing aid

Interventions

Over the counter hearing aid (Lexie) DEVICE

The study will compare user perceptions of two over-the-counter (OTC) hearing aids, with the Lexie B3 Pro serving as the reference device. Participants will be fitted with each device for a predetermined period in a randomized order to ensure balanced exposure.

OTC SF (Lexie)

Comparator over the counter hearing aid DEVICE

The comparator OTC hearing aid will undergo the same evaluation process as the Lexie B3 Pro, ensuring an equivalent and unbiased comparison. Participants will be provided with the comparator device along with its standard user instructions, including any mobile applications or self-fitting guidance designed for independent setup.

OTC SF Competitor

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• HearX SA: lead

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karina C De Sousa, PhD

  hearX Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 14, 2025
• Study Start: July 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share