Cochlear Implants for Single-Sided Deafness: FDA Labels, Medicare and 2026 Costs

Which FDA approvals added single-sided deafness

Two premarket approval (PMA) supplements in the FDA database name single-sided deafness. Both are supplements to implant systems the FDA had already approved:

• MED-EL Cochlear Implant System: PMA P000025, supplement S104, approved July 19, 2019. Applicant: Med-El Corp.
• Nucleus 24 Cochlear Implant System: PMA P970051, supplement S205, approved January 10, 2022. Applicant: Cochlear Americas.

An approval record says what a maker may put on its label and market. It doesn't say whether an implant will help a given person, whether a surgeon will offer it, or whether a plan will pay for it. This page keeps those questions apart and answers only the last one, with the documents we could read.

How each FDA record words the people its label covers

Each approval statement has one sentence that describes who the new label covers. We quote that sentence and nothing more.

• Cochlear, Nucleus 24 (2022): "Individuals 5 years or older who have one ear with a severe to profound sensorineural hearing loss and obtain limited benefit from an appropriately fitted unilateral hearing device and one ear with normal or near normal hearing."
• MED-EL (2019): the approval expands the indications to "patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear".

The Cochlear statement goes on to list hearing-test thresholds that a clinic measures. We don't reproduce them, and we don't say who qualifies: that is a clinical decision made with an implant team.

Does Medicare's national rule include deafness in one ear?

Medicare's national coverage determination (NCD) for cochlear implantation sets the rule for Original Medicare. Its covered indication reads: "Effective for services performed on or after September 26, 2022, cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss". Among the criteria a patient must meet, it lists "bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids".

Two more lines of the same page matter for a one-ear case:

• Section C: "Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation listed in Section B are deemed not eligible for Medicare coverage except as described in Section D below."
• Section D: "CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B when performed in the context of FDA-approved category B investigational device exemption clinical trials", or as a routine cost in clinical trials.

The FDA label changes of 2019 and 2022 didn't change this wording: the covered indication we read on November 7, 2026 still says bilateral. We don't decide anyone's coverage. Ask Medicare, or your Medicare Advantage plan, for a written answer before surgery. Our page on Medicare and cochlear implants covers the full list of criteria.

What Medicare pays the surgeon and the programming visits in 2026

The October 2026 Medicare Physician Fee Schedule file gives a national amount for each professional service. The amounts below are our calculation from CMS's relative value units and conversion factor. They come before the deductible and coinsurance, and they aren't what a hospital charges:

• 69930, implant surgery: $1,059.81 in a facility. The file marks the non-facility amount NA, so no office amount is priced.
• 92603, first programming visit: $95.86 in a facility, $145.63 in an office.
• 92604, later reprogramming visit: $53.44 in a facility, $87.51 in an office.

The surgeon's amount is one bill among several. The hospital or surgery center bills its own facility fee: our cochlear implant cost page gives the 2026 hospital and surgery center rates. None of these amounts says the service will be covered for single-sided deafness; they are what Medicare pays when it is.

What to get in writing before an implant for one ear

Because the national wording names bilateral hearing loss, the paperwork matters more than usual for a one-ear implant. Ask for:

1. A written answer from Medicare or your plan on whether code 69930 is covered for your case, and under which rule.
2. The hospital or surgery center's own written estimate, separate from the surgeon's.
3. Whether the follow-up visits billed as 92603 and 92604 are covered, and how many the plan allows.
4. If the answer is no, the written reason, so that you can appeal it.

For other one-ear options and their costs, see BAHA vs cochlear implant, CROS hearing aid coverage and cochlear implant vs hearing aid.