A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spectacle Hearing Aid.
- Who it may be relevant to
- Registry conditions: Hearing Loss Mixed. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed 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.
Interventions
- Device Spectacle Hearing Aid
wearing hearing aid for effectiveness assessment by hearing tests and questionnaires
Primary outcome measures
- Spectacle Hearing Aid effectiveness [Time frame: 2 weeks]
- Spectacle Hearing Aid safety [Time frame: 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Asssuta ramat hachayal — Tel Aviv
Identifiers
NCT: NCT07282028 · 82CLD