Important Safety Information

The information below is specific to the FDA device. For information specific to the CE-marked device, click here.

The health and safety information contained herein is provided for informational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider while considering the unique characteristics of the patient. Federal Law restricts this device to sale by or on the order of a physician.

Indications for Use

The MAXUM Systems are indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.

Contraindications

The MAXUM Systems are contraindicated for subjects who have conductive hearing loss, retrocochlear or central auditory disorder, active middle ear infections, tympanic membrane perforations associated with recurrent middle ear infections, and disabling tinnitus.

Magnetic Resonance Imaging (MRI) examinations are contraindicated for patients implanted with the MAXUM. Patients implanted with a MAXUM System should not undergo an MRI examination, enter a room where MRI exams are performed, or get close to other strong magnetic fields. If you have a medical or occupational need to be exposed to strong magnetic fields such as a need for MRI examinations or working with MRI equipment, inform your hearing health care professional, your physician or contact Ototronix at (877) 410-4327.

Nickel Sensitivity: MAXUM Implant Assembly, Split Coil versions (P/N M220L, M420L, M220R, M420R) are contraindicated for patients with foreign body sensitivity to metals containing nickel. Where material sensitivity is suspected, appropriate tests should be conducted prior to implantation. (MAXUM Implant Assembly, Full Coil versions P/N M210L, M410L, M210R, M410R do not contain nickel and this contraindication does not apply.)

Warnings Related to the Implant

Magnetic Resonance Imaging (MRI): MRI is contraindicated for patients implanted with the MAXUM. Patients implanted with a MAXUM System should not undergo an MRI examination, enter a room where MRI exams are performed, or get close to other strong magnetic fields. The effects of these exams on the implant are unknown. If an MRI is necessary, the implant should be removed and re-implanted after the exam.
Electroconvulsive Therapy: Electroconvulsive therapy is contraindicated for patients implanted with the MAXUM. Electroconvulsive therapy must never be used on a patient with a MAXUM System implant because it may damage the implant or the patient’s hearing.
Diathermy: Diathermy is contraindicated for patients implanted with the MAXUM. Diathermy must never be applied over the implant because the high currents induced into the implant may damage the implant or the patient’s hearing.
Electroconvulsive therapy: Electroconvulsive therapy must never be used on a subject with a MAXUM System because it may damage the implant or the subject’s hearing.
Cobalt treatment, PET scans, transcranial diagnostic ultrasound, or linear acceleration techniques: The effect of cobalt treatment, PET scans, transcranial diagnostic ultrasound, and linear acceleration techniques on the implant are unknown. Before undergoing any of these procedures, MAXUM System users should consult their physicians about the potential risks.
Magnetic Surgical Instruments: If other surgeries are to be performed in the middle ear space of the implanted ear, avoid using magnetic (ferric) instruments. Such instruments will attract the implant, and may damage the implant or the patient’s hearing.
Electromagnetic compatibility: The MAXUM Systems have been found to comply with the test requirements of EN60601-1-2, Electromagnetic Compatibility for Medical Devices. Compliance indicates the systems are reasonably protected from harmful interference in a typical medical installation. However, these devices may be affected by systems that produce, utilize, or radiate radio frequency energy. If your MAXUM System appears to be affected, try the following solutions to resolve the problem:
- Reorient and / or relocate the interfering device.
- Increase the separation between the MAXUM System and the interfering device.
If these solutions do not resolve the problem, please inform your hearing health care professional, your physician or contact Ototronix at (877) 410-HEAR.
Anti-Theft Detectors and Airport Security Devices: Anti-theft detectors found in retail stores, public libraries, etc., and airport security devices produce electromagnetic fields. Some MAXUM System users may hear distorted sounds when passing through or near one of these devices. Testing with the MAXUM has indicated that the device is not damaged by these systems.
Do not stand near or lean against anti-theft devices in doorways of department stores and libraries. Anti-theft devices in stores and libraries are safe, providing you walk through them at a normal pace. When passing through an anti-theft system, walk though the center of the gates. If only one gate is present stay as far away as possible from it.
If scanning with a hand held metal detector is necessary at airport security stations, warn the security personnel that you have an implanted medical device. Ask them not to hold the metal detector to the device any longer than absolutely necessary. You may wish to ask for an alternate form of personal search.
Radio Frequency Identification (RFID) Systems: RFID is a technology that uses radio waves to exchange data between a reader and an electronic tag attached to an object. RFID Systems are used currently in keyless entry systems, passports and identification, retail sales and asset management, toll roads and many others.
The MAXUM Systems are reasonably protected from harmful interference from RFID Systems. Some MAXUM System users may hear distorted sounds when passing through or near one of these devices. Testing with the MAXUM has indicated that the device is not damaged by these systems.
It is recommended that you keep a separation distance of 6 inches (15 cm) between your MAXUM and items thought to contain RFID systems.
Cell Phone Compatibility: Some hearing device users have reported buzzing sounds when they are using cell phones, indicating that the cell phone and hearing device may not be compatible. According to the ANSI C63.19 standard (ANSI C63.19-2006 American National Standard Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids), the compatibility of a particular hearing device and cell phone can be predicted by adding the rating for the hearing device immunity to the rating for the cell phone emissions. For example, the sum of a hearing device rating of 2 (M2) and a telephone rating of 3 (M3) would result in a combined rating of 5. Any combined rating that equals at least 5 would provide “normal use”; a combined rating of 6 or greater would indicate “excellent performance.”
The immunity of the MAXUM has been found to be M4. While this rating system was created for acoustic hearing aids, the equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied.
NOTE: The performance of individual hearing aids may vary with individual cell phones. Therefore, if you are purchasing a new phone, be sure to try it with your MAXUM prior to purchase. For additional guidance, please ask your cell phone provider for the booklet entitled “Hearing Aid Compatibility with Digital Wireless Cell Phones.” If you have questions regarding these Warnings please inform your hearing health professional, your physician or contact Ototronix at (877) 410-4327.

Precautions Related to the Deep Earmold Impression Procedure

Proper fitting of this hearing device requires the taking of deep-canal impressions. Hearing health professionals should not attempt this type of fitting unless they have completed the MAXUM training course and developed the necessary skills needed to safely make this type of impression. Only the Impression material supplied by Ototronix should be used for deep peritympanic impressions.

Precautions Related to the Device Components

Do not allow others to tamper with or wear any part of the MAXUM Systems. Each system is individually prescribed and use by others could result in bodily injury or damage to the device.
Do not swallow any part of the MAXUM Systems or use in any manner other than that described in this manual. Doing so can result in illness, injury, or damage to the device.
Do not wear the ECA / IPC when engaging in contact sports of any kind. This could result in damage to the ear canal and/or eardrum, as well as damage the device.
Do not get the MAXUM Systems wet. Doing so could cause intermittent performance or damage the device beyond repair. If the device does get wet, remove the battery and store the device in the dehumidifier overnight, leaving the battery door open. If the device still malfunctions, notify your Center.
Do not use hair care products, such as hairspray or gel, while wearing your MAXUM Systems. This may damage the device.
Do not attempt to wear a damaged device. Damage may be caused by heavy impact such as dropping onto a hard surface. Inspect the entire device for damage before continuing to wear the device.
Do not allow any part of the device to be exposed to excessive heat, such as direct sunlight, blow dryer, or flame, or leave on the dashboard or inside of a car. Contact with a hot device may cause minor skin irritation or burns. Heat may also damage the device beyond repair.
Do not attempt to open the Sound Processor except to remove the battery. Exposing or tampering with the internal controls could seriously alter the device performance and output. Only trained professionals at your Center should make adjustments to the internal controls. Notify your Center if you feel adjustments are needed.
Do not ingest batteries; batteries are harmful if swallowed. The button cell batteries used to power the MAXUM Systems are small and could be easily swallowed. Keep them away from children, pets, or anyone who might not understand the dangers associated with swallowing batteries.

IN CASE A BATTERY IS SWALLOWED, IMMEDIATELY CONTACT:
NATIONAL BUTTON BATTERY HOTLINE 1-202-625-3333 OR YOUR LOCAL PHYSICIAN.