Feasibility Evaluation of OtoSet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-10-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerumen Impaction of Both Ears

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OtoSet - Ear Cleaning Sytem

Group Type EXPERIMENTAL

OtoSet - Ear Cleaning System

Intervention Type DEVICE

Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System

Interventions

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OtoSet - Ear Cleaning System

Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No