The battery in OtoSet will need to be fully charged before first use (approximately 2 hours). Plug the provided USB charger into an electrical outlet and then into the device. The left LED will begin to flash blue, signifying that it is charging. The left LED will stop blinking and remain solid blue when OtoSet is fully charged.
Preparing for Use
You can run, on average, approximately 75 cycles with a single charge of your OtoSet. Keep in mind that some patients may require more than one cycle to fully remove earwax.
The ear tip should fit comfortably in the patient’s ear and should not be too tight so as to collapse the silicone tip(s). Once the ear tip(s) is placed on your OtoSet and the headset is fitted to the patient, the ear tip(s) should feel as though they are pulling slightly upwards on their ear canal(s).
Distilled water or saline solution is recommended.
Body temperature (97.7-99.5 °F, 36.5-37.5 °C) distilled water or saline solution should be used with your OtoSet. Test the solution with the provided thermometer to ensure you have the correct temperature prior to filling the solution containers.
70 ml of solution is needed for the cleaning cycle. You can measure this with the provided plastic beaker and/or by viewing the fill line on the solution container(s) on your OtoSet.
Wake up the device with a long press (1 second) of the button. The blue "on" LED will illuminate along with the green LED for the patient's left ear indicator. Using a short button press, select ear(s) to be cleaned and verify corresponding LED(s) is ON.
- One short button press selects patient’s left ear only; the device defaults to the patient’s left ear when turned on
- Two short button presses select the patient’s right ear only
- Three short button presses select both ears
Long press of the button (1 second) to start cleaning procedure.
See “Starting Cleaning Procedure” in Instructions for Use Manual for additional information.
Any irrigation procedure is not advised if the patient has otitis media, vertigo, or is immunocompromised. Any irrigation procedure should not be attempted if patient has PE tubes, severe pain, or active bleeding. If patient has sensorineural hearing loss or tinnitus, an irrigation procedure may be performed with proper precautions.
OtoSet is currently FDA cleared for clinical use on persons aged 18 years and older.
Guide attached ear tip(s) into ear canal(s) while placing your OtoSet on the patient’s head. If possible, ask the patient to hold headset in place while you tighten the head strap until a snug fit is achieved.
The patient should feel the ear tip(s) pulling slightly upward on their ear canal(s) and the head strap should be centered on the head or shifted slightly toward the back of the head. To help ensure a good fit, it is recommended to remove large earrings, eyeglasses, etc. prior to placing the headset.
Before starting the procedure, position the patient's chin slightly upwards as this will help to maintain a good headset fit.
To ensure a good fit, it is recommended to remove large earrings, eyeglasses, etc. prior to placing the headset.
OtoSet Cleaning Cycle
No, the pressure is automatically controlled and optimized to ensure both patient safety and product efficacy.
There can be a few reasons why you may get spillage of the cleaning solution:
Solution spilling from around headset
- The ear tip(s) may not be attached properly to OtoSet. Pause the cleaning cycle (see “Starting Cleaning Procedure” in Instructions for Use Manual) and remove and reattach the ear tip(s). See “Attaching Ear Tips” in Instructions for Use Manual.
- The ear tip(s) may be too big for your patient’s ear; pause the cleaning cycle and recheck the size and fit of the ear tip(s). If necessary, change to a different size ear tip(s).
- The ear tip(s) may not be placed in the ear canal or are not placed properly. Pause the cleaning cycle and re-fit the headset to your patient’s head. See “Fitting OtoSet on Head” in Instructions for Use Manual.
- The headset may not be secure on the patient’s head. Ensure that the headset is secured tightly to the head and that the patient reports that the ear tip(s) feel as though they are pulling slightly upward on the ear canal(s). Pause the cleaning cycle and reposition the headset. See “Fitting OtoSet on Head” in Instructions for Use Manual.
- A large amount of cerumen has blocked the suction channel of the ear tip(s). Pause procedure and check ear tip(s); remove any blockage or replace ear tips(s).
- The ear tip(s) may be damaged. Pause the cleaning cycle and remove and attach a new ear tip(s).
Solution spilling around waste container(s)
- The waste container cap(s) are not closed completely. Pause the cleaning cycle and reattach cap(s). See “Attaching Waste Containers” in the Instructions for Use Manual.
- The waste container(s) may be misaligned to OtoSet. Pause the cleaning cycle then remove and reattach the waste container(s).
- The waste container(s) may be damaged. Pause the cleaning cycle and attach new waste container(s).
No, the direction of the irrigation is pointed toward the top and bottom of the ear canal walls but not directly at the eardrum.
The number of cleaning cycles needed will depend on the level of impaction and the consistency of the cerumen. For some patients with hardened wax, multiple cleaning cycles may be required. Earwax softeners may enhance the performance of OtoSet especially in cases with dry wax. Ideally, the drops are used a few days prior to the procedure. Be sure to visualize your patient's ear canal(s) after each cleaning cycle.
Yes, it does. You should pause the cleaning cycle if your patient is uncomfortable or if there is spillage of the cleaning solution. You can pause the cleaning procedure at any time with a short press of the button on OtoSet. The paused cleaning procedure can be resumed with another short press of the button. The paused cleaning procedure can be canceled with a long press (1 second) of the button.
In the case of cleaning solution spillage, see Section 04 of the Instructions for Use Manual.
If another cleaning cycle is required:
- After removing the headset from your patient’s head, drain waste container(s) into sink by opening bottom waste container caps(s).
- Push bottom waste container cap(s) back into waste containers(s) and ensure fully sealed.
- Repeat steps for “Filling solution Containers", Fitting OtoSet on Head", "Starting Cleaning Procedure" and "After Cleaning Procedure" as seen in the Instructions for Use Manual.
Yes, if moisture is not a concern and will depend on the type of hearing aid. However, after the completion of the procedure, if the patient notes a feeling of fluid in their ear(s), utilize your preferred clinical method for removing/drying any remaining solution from the ear canal(s).
Cleaning Your OtoSet
All external parts of OtoSet can be cleaned with 70% isopropyl alcohol (IPA) wipes. Pay special cleaning attention to the ear pads and head strap pad. Using a clean dampened cloth, wipe the external surfaces to remove residual IPA.
To clean the waste channel: Remove ear tip and waste container, hold OtoSet over sink, and pour 70% IPA through waste channel into sink using a beaker (provided) or similar tool.
Note: OtoSet should be cleaned or disinfected between each patient use. See Instructions for Use Manual for full cleaning instructions.
When the cleaning procedure is complete, drain waste container(s) into sink by opening the bottom waste container cap(s). The plastic waste containers are recyclable after disposing of cleaning solution if infection control is not a concern. Note that cleaning and reusing disposables is not recommended both for infection control concerns but also to ensure correct pressure output.