Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

NCT05274165 | Completed Results FDA Device

• 1 other identifier: SRF-504
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic. After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Trial to Success Rate

  Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.

  Day 30 of study

Study Arms (2)

Group A

ACTIVE COMPARATOR

Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.

Device: Lyric Hearing Aid- Commercially Available

Group B

EXPERIMENTAL

Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.

Device: Lyric Hearing Aid- Experimental Design; Device: Lyric Hearing Aid- Commercially Available

Interventions

Lyric Hearing Aid- Experimental Design DEVICE

Extended wear hearing aid with a fitting modification that is currently not available

Group B

Lyric Hearing Aid- Commercially Available DEVICE

Extended wear hearing aid that is currently available

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate hearing loss
• New hearing aid users with no previous hearing aid experience interested in trying Lyric devices

You may not qualify if:

• middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
• radiation therapy to head or neck area
• participants who need regular MRI testing
• participants who regularly scuba dive or swim underwater

Sponsors & Collaborators

• Sonova AG: lead
• Sound Relief Tinnitus & Hearing Center: collaborator

Study Sites (1)

Sound Relief Hearing Center

Highlands Ranch, Colorado, 80129, United States

Location

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

Results Point of Contact

• Title: Senior Research Audiologist
• Organization: Sonova USCS

phonakaudiologyresearch@gmail.com

630-821-5000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: March 29, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 30, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)