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| Name | Class |
|---|---|
| Assuta Medical Center | OTHER |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Spectacle Hearing Aid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacle Hearing Aid | Device | wearing hearing aid for effectiveness assessment by hearing tests and questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spectacle Hearing Aid effectiveness | Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid | 2 weeks |
| Spectacle Hearing Aid safety | Incidence of device or procedure related adverse events | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yael Corcos, MPH | Contact | 972-54-8106010 | yael@ay-impact.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asssuta ramat hachayal | Recruiting | Tel Aviv | Israel |
for confidentiality reasons
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| ID | Term |
|---|---|
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |