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Harmonix

Safety

Elevate safety information

Plain-language summary · Not medical advice

Elevate is a CE-marked, self-fitting hearing aid (CE Class IIa). This page summarises who it is designed for, when to talk to a doctor first, and how to wear it safely. It does not replace the instructions for use in your box, and it is not medical advice.

This page is a summary. The full instructions for use ship in the box and cover everything here in more detail.

Instructions for use (PDF, 25 MB)

Not sure whether Elevate is right for you? Email support@harmonix.is — and when in doubt, ask a hearing professional.

Who Elevate is designed for

Adults aged 18 and over with perceived mild-to-moderate hearing loss — for example, trouble following conversation in noisy places, or the TV creeping louder. You fit and tune it yourself with the companion app; no clinic visit is required.

Who should see a professional instead

  • Anyone under 18. Hearing loss in children and teenagers should always be checked by a doctor, ideally an ear specialist — it can affect speech and learning, so professional fitting and follow-up matter.
  • People with more significant hearing loss. If Elevate at full strength does not help you enough, that is a sign you need a professionally fitted solution — a hearing professional can do far more for you.

See a doctor first if any of these apply

These can be signs of a condition that needs medical attention before any hearing device is used:

  • A visible deformity of the ear, from birth or injury.
  • Fluid, discharge or blood from the ear within the last six months.
  • Hearing that got suddenly worse in the last six months.
  • Hearing that comes and goes — worse, then better again.
  • Hearing loss in one ear only, or a big difference between your ears.
  • Ear pain or discomfort.
  • A blocked feeling, or a history of excessive earwax.
  • Dizziness, or a spinning or swaying sensation (vertigo).
  • Ringing (tinnitus) in one ear only, or that started recently.

When not to use Elevate

Elevate is not suitable if any of the following applies to you. Speak to a doctor or a hearing professional instead:

  • A closed or malformed ear canal, from birth or from injury.
  • Hearing loss that is unstable, with the level changing often.
  • Ongoing headache, dizziness, ear pain or ringing in the ears.
  • Hearing loss that started suddenly in the last three months, is getting worse quickly, or affects one ear only.
  • Discharge from the ear, or repeated ear infections with pus.
  • An active ear infection, including infection of the middle ear or the eardrum.
  • Hearing loss that comes from the nervous system rather than from the ear itself.
  • A known allergy to any of the materials used in the device.

While you are using Elevate

  • Start at a comfortable volume and increase gradually. If sound is uncomfortably loud or painful, turn it down.
  • If you find yourself turning the volume down again and again, Elevate most likely needs re-tuning in the app.
  • Elevate should not hurt going in. If it does, take it out, check the fit against the instructions and try again — if the pain returns, contact us.
  • Stop using Elevate and speak to a doctor if you notice skin irritation, swelling, a rash, discharge or new pain in or around your ear.
  • Any hearing device can increase earwax build-up — have your ears checked if they start to feel blocked.
  • If your hearing does not improve with Elevate, or gets worse, see a hearing professional.

Handling and general safety

  • Elevate is not hearing protection. Anywhere you would normally wear earplugs, take Elevate out and wear earplugs instead.
  • Do not share your Elevate with anyone else. A device tuned to someone else's hearing can damage yours.
  • Take Elevate out before an X-ray, MRI or CT scan.
  • Keep the buds, ear tips and any loose parts away from children — they are a choking hazard.
  • If an ear tip or any other part gets stuck in your ear, get medical help. Do not dig it out with tweezers or a cotton bud — you can push it further in and damage the eardrum.
  • Do not run Elevate at high volume for long stretches; over time that can damage your hearing.

Possible side effects

Most people have no trouble, but hearing devices can occasionally cause:

  • Dizziness
  • Ringing in the ears (tinnitus)
  • Hearing that feels worse than before
  • Nausea
  • Headache
  • Skin irritation in or around the ear
  • Extra earwax build-up

If any of these appear and do not settle, stop using Elevate and speak to a hearing professional.

What to expect

A hearing aid helps you make more of the hearing you have. It will not bring your hearing back to how it was, and it cannot change the underlying cause of hearing loss — busy, noisy rooms may still be hard work.

Most people need a couple of weeks of regular use before Elevate feels natural, so give it that time before judging the fit. If you have hearing loss in both ears, you will usually get more from wearing both.

Before you buy, check our returns policy so you know exactly where you stand.

Only Elevate is a hearing aid

This page applies to Elevate only. SonaVue audio glasses and TravelerAI open-ear headphones are everyday listening products — they are not hearing aids, and they are not intended to diagnose or manage any medical condition.

Setup & support

Step-by-step self-fitting help lives in our Elevate self-fitting guide, and our team is one email away for anything else.

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