What s New with MED-EL

1. What�s New with MED-EL? MED-EL Corporation August 2003

3. MRI and the MED-EL COMBI 40+ MED-EL is the first and only cochlear implant system with a fixed internal magnet to receive US FDA approval for use with MRI at 0.2-Tesla. Use of MRI with the COMBI 40+ does not require removal of the magnet or any type of additional surgery. Consequently, because there is no incision to heal, MED-EL patients are not forced to experience any period of deafness following an MRI scan. 0.2, 1.0, and 1.5-Tesla scanners are approved for use with MED-EL patients in Europe.MED-EL is the first and only cochlear implant system with a fixed internal magnet to receive US FDA approval for use with MRI at 0.2-Tesla. Use of MRI with the COMBI 40+ does not require removal of the magnet or any type of additional surgery. Consequently, because there is no incision to heal, MED-EL patients are not forced to experience any period of deafness following an MRI scan. 0.2, 1.0, and 1.5-Tesla scanners are approved for use with MED-EL patients in Europe.

4. MRI: Did You Know? The MED-EL cochlear implant system is MRI safe (causing no additional risk to the patient and compatible (causing no significant impact on the device or image quality) at 0.2T with: No need for surgery to remove internal magnet No incision or swelling to heal after MRI scan No recovery time to affect implant use No need to file w/ insurance for surgical costs No need to order replacement internal magnet No need to schedule 2 separate OR times No risk of spontaneous magnet displacement The COMBI 40+ is MRI safe and compatible at 0.2-Tesla, meaning that it causes no additional risk to the patient and no significant impact on the device or image quality. In addition, you won�t need to schedule 2 OR times (1 to remove the magnet before scanning and 1 to replace the magnet after scanning). There is no insurance pre-authorization or claims to file for surgical costs and no incision or swelling to affect implant use and performance. With a fixed internal magnet, there is also no risk of spontaneous magnet displacement and no need to order a replacement magnet from the manufacturer every time the magnet becomes dislodged and/or must be replaced.The COMBI 40+ is MRI safe and compatible at 0.2-Tesla, meaning that it causes no additional risk to the patient and no significant impact on the device or image quality. In addition, you won�t need to schedule 2 OR times (1 to remove the magnet before scanning and 1 to replace the magnet after scanning). There is no insurance pre-authorization or claims to file for surgical costs and no incision or swelling to affect implant use and performance. With a fixed internal magnet, there is also no risk of spontaneous magnet displacement and no need to order a replacement magnet from the manufacturer every time the magnet becomes dislodged and/or must be replaced.

5. Electric-Acoustic Stimulation (EAS) Combined electric and acoustic stimulation is a concept intended for a whole different group of cochlear implant candidates than those currently considered for implantation. This patient group will have significant residual hearing in the low frequencies, with steeply sloping high-frequency hearing loss. A traditional digital hearing aid will provide acoustic sound stimulation to the apical region of the cochlea, and the cochlear implant will provide electrical stimulation to the high-frequency region.Combined electric and acoustic stimulation is a concept intended for a whole different group of cochlear implant candidates than those currently considered for implantation. This patient group will have significant residual hearing in the low frequencies, with steeply sloping high-frequency hearing loss. A traditional digital hearing aid will provide acoustic sound stimulation to the apical region of the cochlea, and the cochlear implant will provide electrical stimulation to the high-frequency region.

6. Electric-Acoustic Simulation (EAS) If we want acoustic hearing to function in the apical portion of the cochlea, we will need to truly implement a �hearing preservation cochlear implant surgery�. In this concept, the electrode insertion only covers the non-functioning region, and one of the key features of this concept is that insertion depth can be somewhat dependent on the extent of residual hearing remaining. We expect that most candidates will have significant hearing loss at 1000 Hz and above, which is about a 20 mm insertion, or one turn of the cochlea. If we want acoustic hearing to function in the apical portion of the cochlea, we will need to truly implement a �hearing preservation cochlear implant surgery�. In this concept, the electrode insertion only covers the non-functioning region, and one of the key features of this concept is that insertion depth can be somewhat dependent on the extent of residual hearing remaining. We expect that most candidates will have significant hearing loss at 1000 Hz and above, which is about a 20 mm insertion, or one turn of the cochlea.

7. EAS Clinical Experience First patient was implanted in 1999 Ongoing European study (Frankfurt and Vienna), with 19 patients implanted Electrode insertion depths 18 - 22 mm In 16 patients, the residual hearing was preserved Audiograms have been stable over the long term (some with experience up to 3 years) Postoperatively, all patients show improved speech understanding 19 patients have been implanted thus far in Europe, only 3 of whom lost residual hearing. Since that time, additional improvements have been recommended to further promote a surgical protocol with a more gentle approach. Postoperatively, all patients show improved speech understanding, and even the patients who lost residual hearing perform better with their implants than they did with their hearing aids alone. Furthermore, they all perform at or above the mean values found in the large COMBI 40+ multicenter study.19 patients have been implanted thus far in Europe, only 3 of whom lost residual hearing. Since that time, additional improvements have been recommended to further promote a surgical protocol with a more gentle approach. Postoperatively, all patients show improved speech understanding, and even the patients who lost residual hearing perform better with their implants than they did with their hearing aids alone. Furthermore, they all perform at or above the mean values found in the large COMBI 40+ multicenter study.

8. Bilateral Cochlear Implantation MED-EL is also very interested in bilateral implantation. To date, more than 330 bilateral patients have been implanted worldwide. Over half of these patients are children.MED-EL is also very interested in bilateral implantation. To date, more than 330 bilateral patients have been implanted worldwide. Over half of these patients are children.

9. The Bilateral Experience More than 30 ongoing research studies Multi-center studies BilCIA, BilCIAKids, LocCIA US multicenter study UK multicenter study French multicenter study MED-EL conducts an extensive number of research studies worldwide. As an example, MED-EL is currently involved in more than 30 ongoing studies in the area of bilateral cochlear implantation alone.MED-EL conducts an extensive number of research studies worldwide. As an example, MED-EL is currently involved in more than 30 ongoing studies in the area of bilateral cochlear implantation alone.

10. Latest Product Developments TEMPO+ Colors Microphone Test Device (MTD) Insertion Test Device (ITD) TEMPO+ Remote Battery Pack Telemic Activity Cover Latest product developments by MED-EL include release of the TEMPO+ BTE speech processor in 4 new classic colors, a Microphone Test Device, Insertion Test Device, and Remote Battery Pack for use of rechargeable batteries with the TEMPO+. A Telemic and Activity Cover will also be available from MED-EL soon.Latest product developments by MED-EL include release of the TEMPO+ BTE speech processor in 4 new classic colors, a Microphone Test Device, Insertion Test Device, and Remote Battery Pack for use of rechargeable batteries with the TEMPO+. A Telemic and Activity Cover will also be available from MED-EL soon.

11. TEMPO+ Colors In addition to the traditional charcoal and beige colors, the MED-EL TEMPO+ BTE is now available in silver, sapphire (blue), ruby (red), and emerald (green). And only MED-EL offers ALL components of the BTE system (speech processor, battery pack and coil) in these classic colors. In addition to the traditional charcoal and beige colors, the MED-EL TEMPO+ BTE is now available in silver, sapphire (blue), ruby (red), and emerald (green). And only MED-EL offers ALL components of the BTE system (speech processor, battery pack and coil) in these classic colors.

12. Microphone Test Device Intended Use: To test the internal microphone of the TEMPO+ or CIS PRO+ Headset. The amplified microphone signal is heard with the use of headphones by a normal hearing person in order to detect any microphone malfunction. The MTD is used to check the function and sound quality of the cochlear implant microphone. It can be used with both the TEMPO+ BTE and CIS PRO+ body-worn speech processors. It is intended for use in pediatric cochlear implant centers and educational settings. A clinician or teacher with normal hearing can use the MTD to listen to the microphone of the speech processor. The signal is amplified slightly and should be free of static or hissing sounds. The MTD is used to check the function and sound quality of the cochlear implant microphone. It can be used with both the TEMPO+ BTE and CIS PRO+ body-worn speech processors. It is intended for use in pediatric cochlear implant centers and educational settings. A clinician or teacher with normal hearing can use the MTD to listen to the microphone of the speech processor. The signal is amplified slightly and should be free of static or hissing sounds.

13. Insertion Test Device (ITD) The Insertion Test Device, or ITD, is a new tool for use during surgery. It facilitates testing for the presence of any cochlear obstruction. By using the ITD, surgeons can determine the need for an alternative electrode array prior to unpacking the implant. If the ITD reveals a need for one of MED-EL�s special case electrodes, the standard device need never be removed from its sterile package. The ITD is designed with the same stiffness and tensile strength as the COMBI 40+ electrode arrays so that it will have the same insertion characteristics as the device to be implanted.The Insertion Test Device, or ITD, is a new tool for use during surgery. It facilitates testing for the presence of any cochlear obstruction. By using the ITD, surgeons can determine the need for an alternative electrode array prior to unpacking the implant. If the ITD reveals a need for one of MED-EL�s special case electrodes, the standard device need never be removed from its sterile package. The ITD is designed with the same stiffness and tensile strength as the COMBI 40+ electrode arrays so that it will have the same insertion characteristics as the device to be implanted.

14. TEMPO+ Remote Battery Pack MED-EL�s Remote Battery Pack is very cost efficient. Using only one AA rechargeable battery, it can power the TEMPO+ for at least one full day of operation. Some patients could see battery life of 3-4 days on just 1 battery.MED-EL�s Remote Battery Pack is very cost efficient. Using only one AA rechargeable battery, it can power the TEMPO+ for at least one full day of operation. Some patients could see battery life of 3-4 days on just 1 battery.

15. Remote Battery Pack Cost to operate MED-EL BTE with Remote Battery Pack (using 3 AA rechargeable batteries provided by MED-EL): $0 for 9 years $2.50 / rechargeable battery thereafter 1,000 recharge cycles AA batteries will be readily available for the life of the patient The Remote Battery Pack is included in the standard patient kit and is shipped with 3 AA rechargeable batteries and a battery charger. The batteries can be reused for approximately 1,000 recharge cycles. Thus, with the 3 batteries provided, MED-EL patient�s can operate their TEMPO+ speech processor for up to 9 years without paying a penny for batteries. Other systems offer only custom designed rechargeable batteries that provide as few as 400 recharge cycles and last less than a day in most cases. These custom batteries can only be purchased directly from the implant manufacturer and are significantly more expensive. AA batteries, on the other hand, will always be readily available and cost about $2.50 each. The Remote Battery Pack is included in the standard patient kit and is shipped with 3 AA rechargeable batteries and a battery charger. The batteries can be reused for approximately 1,000 recharge cycles. Thus, with the 3 batteries provided, MED-EL patient�s can operate their TEMPO+ speech processor for up to 9 years without paying a penny for batteries. Other systems offer only custom designed rechargeable batteries that provide as few as 400 recharge cycles and last less than a day in most cases. These custom batteries can only be purchased directly from the implant manufacturer and are significantly more expensive. AA batteries, on the other hand, will always be readily available and cost about $2.50 each.

16. Telemic Telecoil (Induction loop) Auxiliary Microphone User volume control with OTM switch MED-EL�s new Telemic is currently under review by the FDA and is intended for use in difficult listening environments. It can be connected to the TEMPO+ speech processor using the Angled Battery Pack option and is designed to reduce echoes and disturbing background noise that can interfere with speech understanding. The telecoil setting allows the TEMPO+ to be used with induction loop systems, offered by many museums, theatres, churches, and cinemas. The microphone setting provides an auxiliary microphone option, which can be useful during speech and language therapy or while riding in a car.MED-EL�s new Telemic is currently under review by the FDA and is intended for use in difficult listening environments. It can be connected to the TEMPO+ speech processor using the Angled Battery Pack option and is designed to reduce echoes and disturbing background noise that can interfere with speech understanding. The telecoil setting allows the TEMPO+ to be used with induction loop systems, offered by many museums, theatres, churches, and cinemas. The microphone setting provides an auxiliary microphone option, which can be useful during speech and language therapy or while riding in a car.

17. TEMPO+ Activity Cover Water resistant Absorbs impact (in event equipment is dropped) Covers all controls on straight battery pack and TEMPO+ speech processor Ideal for moist/humid environments and young children The Activity Cover is currently under development and will provide a protective sleeve for protection against water and impact. It will also cover all controls on the Straight Battery Pack, making it an ideal accessory for young children.The Activity Cover is currently under development and will provide a protective sleeve for protection against water and impact. It will also cover all controls on the Straight Battery Pack, making it an ideal accessory for young children.

18. Latest Service Initiatives Remote Consultative Services Hearing Companions Program Educational & Habilitative Outreach Program ESCO Insurance Coverage One-time Replacement MED-EL�s latest service initiatives include: Remote Support, the Hearing Companions Program, Educational & Habilitative Outreach Program, new ESCO insurance coverage, and a one-time replacement for lost or damaged equipment.MED-EL�s latest service initiatives include: Remote Support, the Hearing Companions Program, Educational & Habilitative Outreach Program, new ESCO insurance coverage, and a one-time replacement for lost or damaged equipment.

19. Remote Consultative Services MED-EL Corporation is the first cochlear implant manufacturer to receive FDA approval for use of remote consultation. Remote consultation, or remote support, allows professionals in different locations to communicate via video conferencing and application sharing. MED-EL has organized a remote support area at our headquarters in NC where clinicians can get real time assistance. A video connection and sharing of the desktop image greatly facilitate any consultation.MED-EL Corporation is the first cochlear implant manufacturer to receive FDA approval for use of remote consultation. Remote consultation, or remote support, allows professionals in different locations to communicate via video conferencing and application sharing. MED-EL has organized a remote support area at our headquarters in NC where clinicians can get real time assistance. A video connection and sharing of the desktop image greatly facilitate any consultation.

20. MED-EL has developed a new resource to facilitate communication between potential and existing cochlear implant patients. Access to www.hearingcompanions.com is free and does not require a registration or login procedure. Our Hearing Companions are ready and willing to share their story and their cochlear implant experience. Hearing companions are volunteers that are not paid or trained in any way by MED-EL. Anyone, with any device, can visit the website, search the database, and correspond with a MED-EL Hearing Companion. Simply search the Hearing Companions database and start e-mailing.MED-EL has developed a new resource to facilitate communication between potential and existing cochlear implant patients. Access to www.hearingcompanions.com is free and does not require a registration or login procedure. Our Hearing Companions are ready and willing to share their story and their cochlear implant experience. Hearing companions are volunteers that are not paid or trained in any way by MED-EL. Anyone, with any device, can visit the website, search the database, and correspond with a MED-EL Hearing Companion. Simply search the Hearing Companions database and start e-mailing.

21. The database can be searched using a number of criteria. Patients can find a companion based on age, duration of implant use, age at implantation, pre or post-lingual deafness, etiology, gender, location, etc. With all of these search functions, a potential patient can easily find a suitable companion with whom they would like to communicate.The database can be searched using a number of criteria. Patients can find a companion based on age, duration of implant use, age at implantation, pre or post-lingual deafness, etiology, gender, location, etc. With all of these search functions, a potential patient can easily find a suitable companion with whom they would like to communicate.

22. Educational & Habilitative Outreach Provides services and support to: Teachers and therapists Implant center staff Early identification and intervention programs Projects: Individualized support Educator�s Guide FM Guide Biannual Newsletter MED-EL has recently established an educational and habilitative outreach program. It is designed to provide services and support to teachers, therapists, implant center staff, and early identification and intervention programs. As an example, projects will include individualized support, a new Educator�s Guide, FM Guide, and a biannual newsletter.MED-EL has recently established an educational and habilitative outreach program. It is designed to provide services and support to teachers, therapists, implant center staff, and early identification and intervention programs. As an example, projects will include individualized support, a new Educator�s Guide, FM Guide, and a biannual newsletter.

23. ESCO Coverage Insurance coverage is now available through ESCO (Ear Service Corporation) to MED-EL users in all states at the lowest rates for any cochlear implant system TEMPO+: $120 CIS PRO+: $110 MED-EL also offers excellent coverage under our Manufacturer�s Warranty, Extended Warranty, and Premium Theft, Loss, and Accidental Damage Policies Insurance coverage through ESCO is also now available to MED-EL users. Ear Service Corporation (ESCO) offers a lower cost insurance option, providing a limited number of replacements on the processor and coil over a specified period of time. Coverage may be obtained for multiple speech processor systems or the primary system only. ESCO coverage is available to MED-EL users in all states. Insurance coverage through ESCO is also now available to MED-EL users. Ear Service Corporation (ESCO) offers a lower cost insurance option, providing a limited number of replacements on the processor and coil over a specified period of time. Coverage may be obtained for multiple speech processor systems or the primary system only. ESCO coverage is available to MED-EL users in all states.

24. One-time Replacement MED-EL�s MANUFACTURER�S WARRANTY has been upgraded to include ONE free-of-charge replacement for a stolen, lost or damaged unit. MED-EL has also upgraded our basic manufacturer�s warranty to include one free-of-charge replacement for a stolen, lost, or damaged unit.MED-EL has also upgraded our basic manufacturer�s warranty to include one free-of-charge replacement for a stolen, lost, or damaged unit.

25. Thank you for your interest in MED-EL. For more information on MED-EL, please visit our website at www.medel.com or call our toll free number at 888-633-3524.Thank you for your interest in MED-EL. For more information on MED-EL, please visit our website at www.medel.com or call our toll free number at 888-633-3524.