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Tests treatment safety and results for Hearing Loss Mixed
Official title A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
ClinicalTrials.gov ID: NCT07282028
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Wearing corrective glasses for daily use
- Cognitive ability to understand and follow study instructions.
- The main language used in social interactions is Hebrew
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.