PATIENT INFORMATION MANUAL

Transcription

1 PATIENT INFORMATION MANUAL

2 CAUTION: FEDERAL (U.S.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN READ ALL INFORMATION IN THIS GUIDE BEFORE USING THE MAXUM SYSTEM. CONTACT YOUR HEARING CARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT YOUR MAXUM SYSTEM. CONTACTS FOR INFORMATION AND ASSISTANCE: Doctor: Tel: Center: Tel: Other: Tel:

3 TABLE OF CONTENTS HOW DO WE HEAR?... 4 HOW DO HEARING AIDS WORK?... 7 THE PROBLEMS WITH HEARING AIDS... 8 HOW DOES THE MAXUM SYSTEM WORK? IS A MAXUM SYSTEM RIGHT FOR ME? WARNINGS AND PRECAUTIONS HOW DO MAXUM SYSTEMS DIFFER FROM MY ACOUSTIC HEARING AID? WHAT ARE THE PARTS OF THE MAXUM SYSTEMS? HOW LONG WILL MY MAXUM SYSTEM LAST? WHAT HAPPENS AFTER I CHOOSE A MAXUM SYSTEM? The Deep Ear Impression The Implant Surgery WHAT HAPPENS AFTER SURGERY? Are There Post-Operative Complications Post-Operative Precautions & Care FREQUENTLY ASKED QUESTIONS CLINICAL STUDY SUMMARIES

4 HOW DO WE HEAR? The hearing process begins when sound waves enter the ear and travel from the outer ear to the middle ear through the ear canal. At the end of the ear canal, the sound waves reach the eardrum. When this happens, the sound waves cause the eardrum to vibrate. When the eardrum vibrates, the bones in the middle ear also vibrate. These bones are known as the malleus, incus, and stapes (also known as the hammer, anvil, and stirrup). Together, they make up what is called the ossicular chain. The ossicular chain connects the middle ear to the inner ear. Outer Ear Inner Ear Middle Ear Ear Canal Auditory Nerve The inner ear contains the cochlea, which is filled with fluid, membranes, and tiny hair cells. The vibrations of the ossicular chain cause movement in the fluid of the cochlea. This movement stimulates the hair cells, which are connected to nerve fibers. As the hair cells are stimulated, the nerve fibers send electrical pulses to the brain, and the brain interprets these pulses as speech and sounds. Ear Drum Components of the Human Ear 4

5 What Causes Hearing Loss? There are three types of hearing loss: conductive, sensorineural, and mixed. Mixed hearing loss is a combination of conductive and sensorineural hearing impairment. CONDUCTIVE HEARING LOSS Conductive hearing loss is usually caused by a disease or disorder that affects how sound waves travel through the outer or middle ear. Because of this, the sound waves have difficulty reaching the eardrum or inner ear, and the hearing process is interrupted. This is usually treated with medication or surgery. Conductive loss is caused by a condition or disease that blocks or impedes the transmission of sound through the outer or middle ear. 5

6 SENSORINEURAL HEARING LOSS Most adults with hearing problems have sensorineural hearing loss. This type affects the inner ear and/or the neural pathways. Sound waves can reach the middle ear without difficulty, but there is some type of damage to the inner ear, usually the hair cells or nerve fibers. If the hair cells or nerve fibers are not working correctly, the inner ear loses its ability to transmit the necessary signals to the brain for sound recognition. Sensorineural hearing loss is usually treated with a hearing aid. Healthy Inner Ear Hair Cells Damaged Inner Ear Hair Cells 6

7 HOW DO HEARING AIDS WORK? With hearing aids, the microphone picks up sound which is amplified and sent into the ear canal and tympanic membrane (eardrum) via the receiver, or speaker. The amplified sound pressure in the ear canal vibrates the tympanic membrane and middle ear bones and fluid in the inner ear. The increased vibration stimulates the tiny hair cells in the cochlea (inner ear) causing electrical signals to be sent to the brain for interpretation as speech or sounds. Conventional Hearing Aid 7

8 THE PROBLEMS WITH HEARING AIDS The sound delivery system for hearing aids produces amplified sound (acoustic energy) in the ear canal. Familiar complaints include the presence of feedback or whistling, occlusion (wearer s own voice sounding hollow or having an echo), and sound quality issues. Feedback As the hearing loss becomes more severe, the risk of feedback is increased. Feedback occurs when some of the amplified sound escapes from the ear canal back to the microphone of the hearing aid, thereby creating a feedback loop. Several approaches have been used to minimize feedback including digital feedback reduction, increasing the distance between the microphone and receiver (using a behind-the-ear hearing aid), and/or blocking the ear canal with an occlusive hearing aid shell or earmold. Yet, feedback continues to be an issue for many hearing aid users. Feedback occurs when some of the amplified sound escapes from the ear canal back to the microphone of the hearing aid, thereby creating a feedback loop (whistling sound). 8

9 The use of occlusive earmolds to control feedback traps low frequency sounds in the ear canal. The trapped amplified sounds are transmitted to the inner ear through bone conduction which may cause distortion. This distortion may interfere with the cleanness of the sound, naturalness of sound quality, and/or richness of sound fidelity. Earmolds are also used to provide increased gain by plugging or occluding the canal, thus keeping as much sound energy in the canal as possible. Unfortunately, this also results in what is known as the occlusion effect. The occlusion effect is described as the wearer s voice sounding hollow, muffled, or as having an echo. The common cause of the problems with hearing aids is the use of amplified acoustic (sound) energy being sent down the ear canal. MAXUM changes that. MAXUM does not use a speaker or amplified sound pressure but, instead, provides direct cochlear stimulation. MAXUM technology provides improved sound quality, reduced occlusion and less feedback. Occlusion Distortion Distortion (trapped amplified sounds) can interfere with clarity and sound quality. The Occlusion Effect occurs when a hearing aid completely fills the outer part of the ear canal causing the wearer s voice to sound hollow or muffled. 9

10 HOW DOES THE MAXUM SYSTEM WORK? IPC The MAXUM System works with a magnetic implant attached to the ossicular bones in your middle ear. Implant The two bones used in the process are called the incus and the stapes. For the MAXUM IPC System, after the implant surgery is performed you will receive the Integrated Processor and Coil (IPC). This external component completes your MAXUM IPC System. The IPC houses both the sound processor and the electromagnetic coil. The sound processor in the IPC receives sound, amplifies it, and sends electrical signals to the coil at the tip of the device. This coil changes the sounds to electromagnetic signals, which cause the implant to vibrate. These vibrations travel through the cochlea, stimulating the hair cells and nerves that send impulses to the brain that are interpreted as speech or sounds. The MAXUM System consists of a small rare earth magnet implant and an Integrated Processor and Coil (IPC). 10

11 IS A MAXUM SYSTEM RIGHT FOR ME? Indications 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. Your doctor or audiologist/hearing instrument specialist will perform several audiometric tests and a medical examination to determine whether you are a candidate for the MAXUM. Contraindications The MAXUM is contraindicated for subjects who have: Conductive hearing loss Retrocochlear or central auditory disorder (brain stem disorder) Active middle ear infections Tympanic membrane (ear drum) perforations associated with recurrent middle ear infections Disabling tinnitus (ringing in the ear) 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 Nickel Sensitivity: MAXUM Implant Assembly, Split Coil versions (P/N M220L and M220R) 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 and M210R) do not contain nickel and this contraindication does not apply.) 11

12 WARNINGS & PRECAUTIONS The MAXUM System is proven safe and effective if used and cared for responsibly. The MAXUM IPC System is based on the same implant technology as the previous MAXUM BTE System and showed similar results in a limited confirmatory study conducted on a subset of 10 subjects, 9 of which were from the original (BTE) study, with similar results. The following warnings and precautions should be noted to avoid potential harm to yourself and damage to the device. Warnings Inform your physician that you are implanted with a MAXUM System before having the following medical or surgical procedures: MAGNETIC RESONANCE IMAGING (MRI) EXAMINATIONS 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. ELECTROSURGERY Electrosurgical instruments are capable of producing electromagnetic fields that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents may damage the implant or the patient s hearing. 12

13 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 EN , 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 care professional, your physician or contact Ototronix at 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. 13

14 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 C 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 care professional, your physician or contact Ototronix at (877)

15 Precautions Do not allow others to tamper with or wear any part of your MAXUM System. 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 your MAXUM System 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 IPC when engaging in contact sports of any kind. This could result in damage to the ear canal and/or ear drum, as well as damage the device. Do not get your MAXUM System wet. Doing so could cause intermittent performance or damage the device beyond repair. In the event that 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 hearing care professional. 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 inside of a vehicle. Contact with a hot device may cause minor skin irritation or burns. Heat may also damage the device beyond repair. Do not apply hair care products, such as hairspray or gel, while wearing your MAXUM System. 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 attempt to open the IPC except to remove the battery. Exposing or tampering with the internal controls could seriously alter the device performance and output. Only hearing care professionals should make adjustments to the internal controls. Notify your hearing care professional if you experience any bothersome interference. It is possible that there may be electromagnetic interference, resulting in humming or buzzing sounds, when close to appliances such as televisions, computers, or other electronic appliances. This is not uncommon, and your hearing care professional will help you with the problem. Do not ingest batteries; batteries are harmful if swallowed. The button cell batteries used to power your MAXUM System 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 the National Button Battery Hotline at 1(202) or your local physician. If you experience any medical problems, such as pain or discomfort, which you believe are related to the use of your MAXUM System, or if there are any problems with the functions of your MAXUM System, immediately contact your hearing care professional. 15

16 HOW DO MAXUM SYSTEMS DIFFER FROM MY ACOUSTIC HEARING AID? The MAXUM System delivers sound differently than hearing aids. Rather than trapping amplified sound in the ear canal, the MAXUM delivers sound directly to the inner ear. Ototronix, LLC designs devices and systems that may be used as alternatives to conventional acoustic hearing aids. Data was collected from 95 people participating in a clinical trial to illustrate the safety and effectiveness of the Ototronix MAXUM BTE System with an analog processor. The MAXUM IPC System is based on the same implant technology as the MAXUM BTE System, and may provide the same benefits seen in the MAXUM BTE System study. A limited confirmatory study of the MAXUM IPC with an analog processor was performed on a subset of 10 of the 95 MAXUM BTE System subjects and showed similar results. In addition, a limited confirmatory study of the MAXUM IPC with a digital processor was performed on a subset of 10 of the 95 MAXUM System subjects and showed similar results. Individual results may vary. Acoustic Hearing Aid MAXUM System 16

17 Benefits of the MAXUM System: HEARING OF SOUND Compared to your well-fit acoustic hearing aid, you may perceive a higher fidelity sound. You may also hear more sounds in the speech range, which are mid to high frequency sounds. In other words, you may follow a conversation more easily and it may sound more natural to you. ACOUSTICAL FEEDBACK You may experience whistling or squealing when you increase the volume on your acoustic hearing aid. However, many patients who used the MAXUM System reported no feedback and almost all patients preferred the MAXUM System as having the least amount of feedback. SOUND QUALITY Sounds may be clearer, and more natural, including the sound of your own voice. Most patients preferred the MAXUM System in the area of sound quality compared to their hearing aid. SURGICAL IMPLANT The procedure used to implant the internal portion of the MAXUM System is minimally invasive, and is similar to other surgeries performed through the ear canal (stapedectomy, tympanoplasty). OCCLUSION EFFECT When you speak with your acoustic hearing aid on, you may experience the feeling that you are talking into a barrel or tunnel. This is called the occlusion effect. The MAXUM System has been found to produce reduced occlusion compared to a hearing aid. 17

18 WHAT ARE THE PARTS OF THE MAXUM SYSTEMS? IPC Implant The MAXUM IPC System consists of two components: Implant Integrated Processor and Coil (IPC) The implant is surgically implanted by your physician. The IPC is placed in your ear whenever you want to use the MAXUM IPC System. The IPC houses the sound processor and the electromagnetic coil. See the following pages for illustrations and details on the components of each. Implant The implant consists of a small rare earth magnet sealed in a titanium metal canister. A wire-form ring composed of titanium alloy wire holds the magnet to the incudo-stapedial joint in the middle ear. The implant receives electromagnetic energy from the electromagnetic coil, causing the middle ear ossicles to vibrate. These vibrations travel through the cochlea, stimulating the hair cells and nerves that send impulses to the brain that are interpreted as speech or sounds and improved hearing. 18

19 Integrated Processor and Coil (IPC) The IPC is a custom earmold shell composed of acrylic polymer with an electromagnetic coil at the tip. It also houses the sound processor component of your device. It is custom designed from an impression of your ear canal. The sound processor within the IPC receives and amplifies the sound vibrations and transforms them to electrical signals. The signals are received by the electromagnetic coil at the tip of the IPC. This coil transforms the electrical signals into electromagnetic energy. Toggle Switch Battery Compartment The IPC has the following controls: Battery Compartment Toggle switch to change programs HOW LONG WILL MY MAXUM SYSTEM LAST? Scientific literature shows that this magnet in the implant retains its properties for a length of time that exceeds the average human life-span. Data from an on-going study shows that the life expectancy of the external IPC of the MAXUM System is shown to be a minimum of four years when exposed to an average frequency of 1000 Hz and used an average of eight hours a day. At that point, wearers have the option to repair or replace the IPC. 19

20 WHAT HAPPENS AFTER I CHOOSE A MAXUM SYSTEM? The Deep Ear Impression WHY DO I NEED IT? In order to make sure that your MAXUM System is as comfortable as possible, the IPC is custom designed to fit your individual ear canal shape. Your doctor will make an impression of your ear canal, and your IPC will be designed from that mold. HOW IS IT DONE? The doctor may use a topical anesthetic on the ear canal walls to make the procedure comfortable. A light oil will be used to coat the ear canal, making the impression easier to remove. Your ear canal will then be filled with the impression material. It will take a few minutes for the impression material to set, and then the impression will be removed from your ear. After the impression is completed, it will be sent to Ototronix so that your custom IPC can be made specifically for your ear. ARE THERE RISKS WITH THE DEEP EAR IMPRESSION? This procedure, developed as a result of a similar procedure widely used in the hearing aid industry, was tested in a 103 patient trial. Possible adverse events which were observed in clinical studies include a possible hematoma (blood blister) of the ear canal. The hematoma resolves naturally in a short healing period. There is also a slight risk of puncturing or perforating the ear drum, which generally requires remedial surgery to correct. There is a very slight risk of damaging middle ear structures, and a very slight risk of hearing loss (conductive or sensorineural). During an examination, your physician may use a device called the search coil to ensure that your implant is in proper alignment. This device may cause minor tympanic membrane or ear canal irritation that resolves itself without treatment. 20

21 The Implant Surgery WHY DO I NEED IT? The implant is placed on the joint of the incus and the stapes in the middle ear, which is known as the incudo-stapedial joint. The implant must be placed on these bones in order to cause increased vibrations of the ossicular chain for amplification of sound to occur. Surgery is necessary to reach this portion of the middle ear and safely position the implant in the most effective place to stimulate the middle and inner ear. 21

22 HOW IS IT DONE? A local anesthetic is used to numb the middle ear and the ear drum area. The length of the surgical procedure varies for each patient but is typically less than an hour. Patients are usually discharged the same day. The least invasive method of reaching the middle ear is through the ear canal. In order to gain access to the bones in the middle ear on which the implant must be placed, a small incision will be made in the area between the tympanic membrane (ear drum) and the ear canal. After reaching the middle ear area, the surgeon will separate the joint between the incus and the stapes. The wireform ring of the implant will be placed around the end of this joint, holding the magnet in place. The joint then naturally rejoins during the following healing period. ARE THERE RISKS WITH THE SURGICAL PROCEDURE? The MAXUM Systems have been proven safe and effective in all clinical testing. However, with any surgical procedure there are associated risks. Potential complications of surgery seen in clinical studies include normal risks such as postoperative bleeding, postoperative infection, nausea and vomiting, and the risks associated with anesthesia. There is a small risk of tympanic perforation (tear in the ear drum) which may be corrected surgically. There is also a remote risk of facial paralysis or weakness, which may be permanent or temporary. There may also be a temporary or permanent disturbance of balance or taste, vertigo (dizziness), tinnitus (ringing in the ear), and/or a decrease of hearing (conductive or sensorineural). 22

23 WHAT HAPPENS AFTER SURGERY? It is likely that you will be discharged the day of surgery, and your first follow-up appointment should be scheduled with your surgeon at that time. When your ear has healed completely from the surgery, you will be fitted for the external components of your device during a ten-week follow-up appointment. Are There Post-Operative Complications? A few hours after surgery you may notice a loss of hearing. This is a normal and temporary reaction to the surgery. It should begin to improve shortly thereafter and you will notice continued improvement for many weeks following your surgery. It is common to experience some ear pain and swelling after surgery. This is temporary, and will subside with time. It is also possible that a hematoma (blood blister) or tympanic membrane perforation may occur, both of which may resolve themselves or can be resolved with medicine or surgery. In order to minimize these complications, many types of movement and activities will be restricted temporarily. You will also need to take special care of your ear while it is healing. The post-operative care and precautionary rules should be followed to avoid excessive pain and damage to your ear, hearing, and the implant. When your ear has healed completely from the surgery, you will be fitted for the external components of your device during a tenweek follow-up appointment. 23

24 Post-Operative Precautions Do not exercise or move your head quickly for the first two weeks after surgery. Do not engage in vigorous exercise or contact sports, such as basketball, football, soccer, hockey, etc. for three months Do not wear external components of the device in the ear canal when engaging in contact sports at any time. Do not blow your nose for three weeks. Any accumulation in the nose may be drawn back and expectorated through the mouth. Keep your nose and mouth open while sneezing. Do not blow on musical instruments for three weeks. No swimming for two months. Avoid diving until advised. Flying is permissible after one week, but only on commercial airlines for the first month. Later, when you are using your MAXUM device, report to your doctor any swelling or pain you experience in the external ear canal. Post-Operative Care Change cotton in ear daily for one week. Use only sterile cotton. Wash your hands for two to three minutes with soap and water before touching your ear. If necessary, the external ear may be cleansed with cotton dampened with rubbing alcohol. Do not wash your hair or get water in the ear for one week after surgery and keep water out of the ear canal for three weeks. A cotton plug placed in the canal and covered with Vaseline will prevent water entering the ear while washing the face or taking a shower. Do not use Q-Tips to clean your ear. It is very normal for hearing to regress a few hours after surgery. It will be very distorted and poor for some time. Do not be discouraged over this. Often the hearing will be poor initially but will continue to improve for many weeks after surgery. Call your physician if you develop a cold or have an elevation in temperature above normal. Please call your physician if you should have excessive pain or dizziness during the first few weeks following surgery. Call your physician if there is excessive pain or drainage. A small amount of bloody drainage on the cotton the first few days after surgery is not unusual. 24

25 FREQUENTLY ASKED QUESTIONS WILL THE IMPLANT WORK WITHOUT THE EXTERNAL DEVICE? All parts of your MAXUM device work together as a system the implant will not improve your hearing without the IPC. If for some unforeseeable reason you choose not to have those components fitted, or if these external portions of the system cannot be fitted, the systems will not be able to amplify sounds for you. It is anticipated that users will have nearly the same hearing (-4.2 db average) as before the implant as proven in MAXUM BTE System clinical trial data. However, individual results may vary. CAN I WEAR MY HEARING AID IN MY IMPLANTED EAR? CAN THE IMPLANT BE REMOVED? The implant can be removed through a similar surgical procedure with similar risks. It may also be re-implanted once the structures of the middle ear have been allowed to heal and can withstand surgery. WILL I NEED FUTURE SURGERY IN ORDER TO UPGRADE MY DEVICE? Future upgrades of the external parts of your device will not require a change to your implant. However, as future technologies become available, it will be possible to upgrade the implant through similar surgery. The implant does not interfere with your hearing aid. Allow two weeks after your implant surgery for healing, and you may then resume use of your hearing aid in the implanted ear if desired. 25

26 CLINICAL STUDY SUMMARIES Clinical Study Summary MAXUM IPC System with a Digital Processor A limited confirmatory study of the IPC with a digital processor was conducted on a subset of 10 subjects, 9 of which were from the original (BTE) study, with similar results. Clinical Study Summary MAXUM BTE System One hundred-three (103) subjects underwent the implant procedure with the MAXUM BTE System and were fit with the BTE style Sound Processor. The following clinical study summary is based on ninety-five (95) subjects who had completed 20-week assessments. The assessment compared preoperative results with an optimally fit acoustic hearing aid in the ear to be implanted to post operative results with the MAXUM System. Optimally fit as defined by the clinical study included insertion gain matching using National Acoustic Laboratories-Revised (NAL-R) prescriptive target ranges (+5 db for 500, 1000, and 2000 Hz and +12 db for 3000 and 4000Hz) and evidence of improvement in aided benefit. Subjects were tested to find hearing thresholds, sound field thresholds, speech testing in quiet and noise, aided benefit, and subject perceptions. All items showing improvements were determined to be statistically significant. More detailed information about the MAXUM System clinical results is located in the Clinician s Guide. 1. For most subjects, the change in residual hearing was not significant. Average decrease in air conduction thresholds at 20 weeks was 4.2 db across the frequency range of 250 to 8000 Hz. Average bone conduction thresholds decreased by 1.1 db. Few subjects (10/95 or %) had greater than 10 db of change by air conduction. Few subjects 35 (4/95 or 4%) had greater than 10 db of change by bone conduction. 2. There was an average increase in functional gain of 7.9 db with the MAXUM compared to their acoustic hearing aid. For the high frequencies of 2000, 3000, and 4000 Hz, there was an average increase in functional gain of 9.6 db. Mean Functional Gain (db) Gain Comparison Conventional Hearing Aid K.5K 1K 2K 3K 4K 6K Frequency (Hz)

27 3. The Articulation index score results showed an improvement of 11.9% with MAXUM. The MAXUM System shows an improved audibility over acoustic hearing aids. 4. Speech recognition in quiet showed a 5.3% improvement with the MAXUM when compared with the subjects acoustic hearing aids. 5. Speech testing in noise results with the Speech Perception in Noise (SPIN) test showed no difference between the MAXUM System and acoustic hearing aids. 6. The Abbreviated Profile of Hearing Aid Benefit (APHAB) scores showed an improvement of approximately 20% across three different sub-scales with the MAXUM when compared to acoustic hearing aids. 7. When subjects compared the MAXUM with their acoustic hearing aid in the Hough Ear Institute Profile* (HEIP) test, the results showed that: 100% 90% 80% 84% 70% 60% 50% 40% 30% 20% 10% 0% Overall Satisfaction Patient Preference 88% Sound Quality 99% Less Feedback 84% Less Occlusion Conventional Hearing Aid a. Out of 94 subjects responding, 84 of those subjects (89%) preferred the MAXUM in terms of overall satisfaction. b. 63 of 94 (67%) reported feedback with their acoustic hearing aids. 8 of 94 subjects (8.5%) reported feedback with the MAXUM. Out of 94 subjects responding, 93 of them (99%) preferred the MAXUM as having the least amount of feedback. c. 50 of 92 subjects (54%) reported occlusion with their acoustic hearing aids. 21 of 92 subjects (23%) reported occlusion with the MAXUM. d. Out of 94 subjects responding, 84 of those subjects (89%) responded that they preferred the MAXUM over their acoustic hearing aids in the area of sound quality. e. 21 of 41 (51%) subjects reporting tinnitus pre-implant reported that their hearing aid decreased their perceptions of tinnitus. 20 of 30 (67%) subjects reporting tinnitus post-implant reported that the MAXUM System decreased their perception of tinnitus. *HEIP is a validated but not standardized questionnaire addressing the patient s perception of the presence of tinnitus, feedback, and occlusion as well as sound quality judgments and device preference. 27

28 Patient Support: (877) 410-HEAR or (281) Ototronix, LLC I-45 North Houston, Texas USA CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician Ototronix, LLC. All rights reserved. MAXUM is a trademark of Ototronix, LLC. P/N EN Rev. D