Audition Technology
Use and Maintain
Earcare
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Earcare importance
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Earwax remover drops
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Otoscope
Earcare importance
Earcare is important to maximize the benefits of ATLAS OTC Hearing Aids.
Protect ear health
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Regular treatment of common hearing aid use problems such as earwax buildup
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Timely detection of ear problems, described as ‘Red Flags’ by FDA, and seeing an Ear-Nose-Throat (ENT) specialist
Maximize hearing aid performance
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Improve muffled sounds, whistling
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Prevent damage to hearing aid by earwax, ear secretions
Improve the safety of wearing hearing aids
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Check for the proper placement of eartips inside the ear
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Check that eartips are not touching the eardrum
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Check if a loose eartip has been accidentally left behind in the ear
Engage with carepartner, healthcare professional
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Support with ear canal cleaning and checking problems
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Know when to see a healthcare professional
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Share ear health information with a healthcare professional
Earwax Remover Drops
What it does
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Indicated to aid to soften, loosen, and remove excessive earwax (cerumen)
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The medication releases oxygen and foams when it comes in contact with skin
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The foaming breaks up and clears earwax
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It also contains glycerin for moisturizing the skin
How it supports ATLAS OTC Hearing Aid use
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Earwax is natural and protective—but too much can block sound and damage hearing aid
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Regular use of hearing aids can make ears generate more wax and block ear canal
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The earwax can get into the eartip and eartube of the hearing aid and block travel of the amplified sound for you to hear
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Blockages can reduce volume, clarity, and even cause feedback or whistling
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Routine care keeps ears healthy, helps you hear best with hearing aids and protects hearing aids from damage
Meets current FDA standards
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OTC drug product for topical (external) use per FDA OTC Monograph M014
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Carbamide peroxide 6.5% (active ingredient) formulated in an anhydrous glycerin vehicle
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Listed on FDA’s database for Over-the-Counter (OTC) drug products
Notes
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Read and follow: Use Instruction and Warnings provided by the product manufacturer
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For safe use: Wash hands before use, avoid dropper tip touching the ear
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Avoid: Cotton swabs (they often push wax deeper), sharp objects (these can cause serious damage)
Otoscope
What it does
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Handheld tool that lets you see inside ear canal by showing live picture on phone. You will need to download App provided by the ooscope manufacturer
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Helps spot wax buildup, infection or blockage
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Help with hearing aid placement and safe use
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Share ear images with a caregiver, healthcare professional
How it supports ATLAS OTC Hearing Aid use
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Supports following FDA Warnings and Cautions for OTC Hearing Aid use
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FDA warning about certain ear problems (‘Red Flags’), self-checking for them and needing to see an ENT specialist
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FDA caution about the eartip getting stuck in your ear and getting medical help as soon as you can
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Supports safe hearing aid use by helping you see eartip placement and making sure it is not touching the eardrum
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Caregiver can also check ear canal and monitor ear health over time
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Helps prepare for medical visits for ear problems​
​How to check for FDA’s ‘Red Flag’ Symptoms for Ear Problems ​
Normal eardrum
The light shines off the eardrum
Image from Merck Manual Consumer version
Symptom: Your ear has a birth defect or unusual shape. Your ear was injured or deformed in an accident.
Look for: Unusual shapes or signs of past injury or deformation in ear canal and eardrum.
Trauma signs like a ruptured eardrum, bleeding, bruising, ear canal damage.
Symptom: You saw blood, pus, or fluid coming out of your ear in the past 6 months.
Look for: Fluid, pus, unusual discharge, residue in the ear canal. Signs of infection or perforation of eardrum.
Symptom: Your ear feels painful or uncomfortable.
Look for: Outer ear infections, inflammation, blockages, foreign objects in ear canal. Swelling, infection, irritation.
Symptom: You have a lot of ear wax, or think something could be in your ear.
Look for: Unusual earwax buildup or foreign objects in ear canal.
Symptom: You get really dizzy or have a feeling of spinning or swaying (called vertigo).
Look for: Middle ear infection, swelling, fluid near eardrum.
Symptom: Your hearing changed suddenly in the past 6 months.
Look for: Trauma, infection, wax blockage, or eardrum issues. Earwax impaction, infection, or foreign body in canal.
Symptom: Your hearing changes: it gets worse then gets better again.
Look for: Changes due to intermittent fluid buildup (e.g. from allergies or infections).
Symptom: You have worse hearing in one ear.
Look for: Compare both ear canals for wax, redness, debris.
Symptom: You hear ringing or buzzing in only one ear.
Look for: Wax buildup, infections, structural abnormalities.
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Use the otoscope to recognize these red flags earlier, avoid unsafe self-treatment and see a healthcare professional, preferably an ENT specialist.
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You can also share otoscope images with the ENT specialist to have a full discussion on better understanding of the images, what treatment is needed and when to resume wearing hearing aids.
Product meets current FDA standards for an otoscope
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FDA medical device 2CFR874.4770 for otoscope
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Intended to allow inspection of the external ear canal and tympanic membrane (eardrum) under magnification
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Listed on FDA’s database
Notes
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Read and follow: Use Instruction and Warnings provided by the product manufacturer
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For safe use: Wash hands before use, turn on the light and gently pull the outer ear back and up, insert the otoscope gently into the ear canal. Clean otoscope after each use.