Feasibility Evaluation of OtoSet

SafKan

Status: Completed

Conditions: Cerumen Impaction of Both Ears

Treatments: Device: OtoSet - Ear Cleaning System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04743817

SK-0119

Details and patient eligibility

About

This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Full description

This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
• Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
• Subject has life threatening illness
• Subject has immune deficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

OtoSet - Ear Cleaning Sytem

Experimental group

Treatment:

Device: OtoSet - Ear Cleaning System