Essentia / Devices / Cochlear Implant
Device Lab 26
Cochlear Implant
The processor sits behind the ear on a hook and a coiled cable runs up to a coil held over the implant by a magnet. Microphones sit at the top of the processor, where an ear would have collected sound.
Also called: Cochlear Implants. Arabic: زراعة القوقعة. Device Lab 26 of 69 in BMEssentia Medical City, 2 configurations.
Overview: the configurations
Behind-the-ear sound processor
The processor sits behind the ear on a hook and a coiled cable runs up to a coil held over the implant by a magnet. Microphones sit at the top of the processor, where an ear would have collected sound.
Single-unit off-the-ear processor
Everything is inside the coil: processor, battery and microphones all sit in one disc held on the head by the same magnet. There is no cable and nothing behind the ear at all.
How it works: the main parts
What each part does, from the Cochlear Implant lessons in the 3D Device Lab.
- Sound processor
- The body behind the ear. It holds the microphones, the processing, the controls and the battery, and it is the part a recipient owns, charges, drops and replaces every few years.
- Microphones and inlets
- Two small inlets on the upper edge of the processor. Everything this system will ever deliver enters through them, and they are open to weather, sweat and hairspray.
- Power source
- A module that clips onto the bottom of the processor. It powers the external half and, through the link, the implanted half as well.
- Earhook and retention
- The moulded hook over the top of the ear. It carries the weight of the processor and decides whether it stays on a running child.
- Coil cable
- The coiled lead between the processor and the coil. It is the single most replaced part of this whole system, and the only external part whose failure reliably looks like something else.
- Transmitting coil
- The disc on the side of the head. It holds the transmitting antenna and the magnet, and it is the last external part before the signal leaves the outside world.
- Retention magnets
- Two magnets, one in the coil and one in the centre of the implant, holding the coil over the receiver through the scalp. It is the only thing keeping the external half attached to the person, and it is the only purely mechanical link in a chain that is otherwise electrical from end to end.
- Receiver-stimulator
- A sealed electronic package the thickness of a coin, sitting in a recess in the skull under the skin. It receives an instruction through the scalp, and produces current at particular contacts on the array.
Common faults and what to check
Most reported device problems (FDA MAUDE)
| Device problem | Reports |
|---|---|
| Appropriate Device Problem Term/Code Not Available | 15,080 |
| Mechanical Problem | 7,330 |
| Device Operates Differently Than Expected | 6,112 |
| Impedance Problem | 5,803 |
| Output Problem | 5,255 |
| Explanted | 4,198 |
Raw counts of adverse event reports for this device type (FDA product code MCM), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.
Planned maintenance checks
From the BMEssentia procedure library: every 12 months, about 20 minutes, electrical class II, applied part type BF.
Implants and processors are the manufacturer's; the audiology department maintains the fitting interface and loan processors.
| Check | Pass when |
|---|---|
| Fitting interface and loan processors Inspect the interface, cables, coils and microphones of loan processors. | No damage. |
| Communication test Run the manufacturer's processor and coil test. | Pass. |
Test instruments: Manufacturer's test equipment for processors.
Recent FDA recalls
| Recall | Product and reason |
|---|---|
| Z-2283-2026 2026-06-01 | Advanced Bionics, LLC: Brand Name: HiResolution" Bionic Ear System Due to incorrect shelf-life expiration date. Root cause: Under Investigation by firm. |
| Z-1950-2026 2026-04-27 | Advanced Bionics, LLC: Brand Name: HiResolution" Bionic Ear System The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery. Root cause: Under Investigation by firm. |
| Z-1493-2026 2026-03-05 | Advanced Bionics, LLC: Brand Name: HiResolution Bionic Ear System Behind-the-ear sound processer packaging label is different then included product. Root cause: Under Investigation by firm. |
| Z-1813-2025 2025-05-22 | Advanced Bionics, LLC: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Due to incorrect the battery charger being packaged and distributed. Root cause: Under Investigation by firm. |
| Z-3057-2024 2024-09-06 | MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits, labeled as: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Root cause: Under Investigation by firm. |
From the FDA recall database (openFDA), newest first, imported 2026-10-22. 32 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.
Learn it, see it in 3D, ask about it
- Ask Essentia about the Cochlear Implant: answers from named sources, with the device open in its 3D Device Lab beside the answer.
- The Cochlear Implant on the BMEssentia Platform: the Device Library course, 13 sections from physics to maintenance.
- BMEssentia Medical City: Device Lab 26, the Cochlear Implant fully assembled in 3D, with lab tasks and the simulations.
Previous: VNS. Next: Insulin Pump. All 69 devices.
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