A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy

Nuance Hearing

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Hearing Loss Mixed

Treatments

Device: Spectacle Hearing Aid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07282028

82CLD

Details and patient eligibility

About

Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy

Full description

Screening Written informed consent must be obtained for each study subject prior to the commencement of the study. Upon verification of eligibility and execution of informed consent, subjects will be assigned a study code.

The study comprises two groups, stage 1 will include up to 30 participants. Stage 2 will include up to 29 participants. Stage 1 will be conducted before Stage 2, and individuals enrolled in Stage 1 will not be eligible to participate in Stage 2. The eligibility criteria for each group are outlined below.

Screening procedures include:

ICF signature and process
Eligibility Assessment
Data collection: such as Age, Gender, demographic, ENT medical History
Otoscopy performed by ENT physician
Audiometry (Air conduction and bone conduction thresholds) might be performed as part of any other test day.
Spectacle Hearing Aid calibration and Fitting (this activity is subjected to test with Spectacle Hearing Aid ).
REM, aided only (optional) might be performed as part of any other test day.
Optometrist- for glasses prescription (stage 2 only) Stage 1 :This stage involves hearing evaluation tests , which will be conducted over up to four visits, depending on participant cooperation. Each visit will be scheduled on consecutive days or up to 3 weeks apart, based on the participant's and study staff availability.

Stage 2 : After completing the screening visit, each participant will attend two additional visits. At the enrollment visit, participants will receive their Spectacle Hearing Aid along with the prescribed lenses. They will undergo training using the device and will be asked to fill out questionnaires and performed hearing tests. Additionally, the device application and Electronic Patient-Reported Outcome (ePRO) will be installed on the participants' smartphones, and a demonstration will be provided. Participants will then be required to complete the ePRO daily until the study concludes. Functional auditory test battery will be conducted. Few weeks later, participants will return to complete questionnaires.

Enrollment

89 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults aged 18 years and older
Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud
Wearing corrective glasses for daily use
Cognitive ability to understand and follow study instructions.
The main language used in social interactions is Hebrew
Participants must be willing to use the investigational device according to the instructions for use during the study period
Participants must be able to use a smartphone

Exclusion criteria

Hearing loss >55 dB HL
Prior hearing aid usages for the last 12 months
Medical history of cognitive or neurological impairment.
Active inflammatory conditions affecting the ear
Asymmetric or unilateral hearing loss - more than 15dB between ears in PTA4- based on screening or hearing test from the last 18 months.
participation in stage 1 study
Congenital ear defect or a deformed or injured ear
In the past 6 months discharge of blood, pus or fluid
Wax that might disturb REM test
Sudden hearing loss in the past 6 months
Wearer of electromagnetic medical device
Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI