A Proven Natural Pathway to Better Hearing

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Cori Robinson
5 years ago
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1 FOR PROFESSIONALS A Proven Natural Pathway to Better Hearing A BONE CONDUCTION HEARING SOLUTION

Effective Solutions Baha can deliver amplification more effectively than air conduction hearing aids for suitable candidates.

2 Rerouting Sound Naturally Cochlear Baha offers a natural pathway to sound. It is a simple and effective hearing solution for people with conductive hearing loss, mixed hearing loss and Single-sided Sensorineural Deafness (SSD). Effective Solutions Baha can deliver amplification more effectively than air conduction hearing aids for suitable candidates. 1, 2 It bypasses the conductive element of the hearing loss, delivering sound directly to the cochlea with less gain and distortion. Proven Outcomes The Baha System is proven by more than 77, users, and its benefits have been documented in hundreds of clinical articles over more than 3 years. Simple and Safe Baha is an implantable hearing solution that can be tested before use. Surgery is a straightforward procedure, often in an outpatient scenario. This involves no risk of further hearing loss, and once fitted Baha requires minimal aftercare. Cochlear Baha 3 Sound Processor (BP) actual size Cochlear Baha 3 Power Sound Processor (BP) actual size Arnold, Baha user 2

We hear sound in two ways through air conduction and bone conduction. The Cochlear Baha System takes advantage of our natural ability to hear through bone conduction.

3 We hear sound in two ways through air conduction and bone conduction. The Cochlear Baha System takes advantage of our natural ability to hear through bone conduction. Benefits 3 db Air-bone gap or more? Choose Baha... When the conductive component is greater than 3 db, Baha should be the amplification method of choice. 1, 2 Baha bypasses the conductive element delivering amplification more effectively than air conduction hearing solutions to these patients. In mixed hearing losses, air conduction hearing devices must compensate for both the conductive and sensorineural element. Unlike sensorineural losses that are amplified according to the half-gain rule, the conductive component requires up to % compensation. 3 By completely avoiding the conductive element and delivering sound directly to the cochlea, Baha reduces required gain, producing less feedback and distortion. In Single-sided Sensorineural Deafness, Baha will bypass the deaf ear entirely and deliver sound directly to the hearing cochlea. This will overcome the head shadow effect, which leads to improved speech understanding 4, 5, 6 and 3 sound awareness. Choose Baha... When your patients struggle with: Insufficient loudness Feedback and distorted sound quality Draining ears or malformed ear canals Sore and irritated ears No hearing from one side Better comfort and better sound quality Baha clients do not need to battle with earmolds that can cause sore or irritated ears. Nor do they need to accept distorted sound and insufficient loudness from air conduction aids in the struggle to compensate for the conductive component. They can also say goodbye to drawbacks like cables and skin pressure associated with CROS and conventional bone conduction devices. + Benefit Air/Bone Gap > 3 db? Baha System Outperforms Hearing Aids 1 Comparative Benefits of Baha vs Hearing Aids for Mixed Hearing Loss Baha 3 Hearing Aid Air/bone gap Baha performance HA performance 3 db HL Conductive Loss As the air/bone gap increases, hearing aid performance decreases. Baha performance is not affected. Julian, Baha Softband user 4

4 Proven The Baha System has proven to be an effective hearing solution 2, 4, 5, 6, 7, 8, 9, 1 and several clinical studies demonstrate patient benefits. Conductive Losses 'Bypassing the Roadblock' With the Baha System, the conductive roadblock is completely bypassed by rerouting the sound directly to the cochlea. There are numerous studies detailing the advantages of bone conduction for these patients. 7, 8 Typical causes of conductive loss: Cholesteatoma Chronic otitis media Congenital aural atresia External otitis Genetic causes Otosclerosis A practical, effective solution in cases of draining ears, atresia or malformations. Less saturation, distortion and feedback than conventional hearing aids due to reduced required gain. No discomfort or infections due to large earmolds K 2K 4K 8K K 3K 6K An audiogram representing total conductive hearing loss. Angle brackets indicate bone conduction thresholds. Circles indicate air conduction thresholds K 2K 4K 8K K 3K 6K Aided Baha thresholds indicating the sound-field thresholds that could be achieved from a Baha for people with a conductive hearing loss. Mixed Losses 'Targeting the Sensorineural' Baha is an effective solution for mixed hearing losses because it totally bypasses the conductive element of the hearing loss and only needs to address the sensorineural component. Studies suggest that Baha will improve speech understanding in mixed hearing loss. 2, 9 Typical causes of the sensorineural component: Disease related factors Genetic causes Noise trauma Ototoxic treatments Presbycusis Cochlear otosclerosis Significantly less required gain means that sufficient amplification is available to compensate for a mild to moderate degree of sensorineural impairment. Baha performs significantly better than air conduction hearing aids in terms of aided thresholds, speech perception measurements and subjective reports. 2 Less saturation, distortion and feedback due to reduced required gain K 2K 4K 8K K 3K 6K An audiogram showing an example of significant mixed hearing loss. Angle brackets represent bone conduction thresholds. Circles represent air conduction thresholds K 2K 4K 8K K 3K 6K Example of typical aided soundfield thresholds following the fitting of a Baha for a person with mixed hearing loss. More comfortable because it doesn t require any earmolds. Single-Sided Sensorineural Deafness 'Eliminating the Head Shadow' For people with Single-sided Sensorineural Deafness (SSD), a number of studies 4, 5, 6 indicate that the Baha System effectively transfers sound from the deaf side directly to the healthy cochlea, eliminating the head shadow effect. Typical causes of SSD: Acoustic neuroma tumor Genetic causes Ménière s disease Neurological degenerative disease Ototoxic drugs Sudden deafness Surgical interventions Trauma Studies 4, 6 indicate that Baha provides a superior solution compared to a Contralateral Routing of Signal (CROS) hearing aid. Substantial subjective benefit reported 4, 1 from several clinical studies. Reduces the head shadow effect and provides better overall sound awareness. Improved speech understanding in noisy environments. 6 Keeps the healthy ear free K 2K 4K 8K K 3K 6K An audiogram representing an SSD hearing loss. Angle brackets indicate no response bone conduction thresholds for the right deaf ear. Circles represent no response air conduction thresholds for the same ear. Crosses represent air conduction thresholds for the left (good) ear K 2K 4K 8K K 3K 6K Aided Baha thresholds demonstrating good audibility of sounds transferred from the right side to the left cochlea for a client with SSD. 1

The Baha System consists of three parts: The processor detects sound, cleans, amplifies and transforms it into vibrations.

The titanium implant transfers sound vibrations directly to the cochlea via bone conduction.

conduction devices uncomfortable and ineffective. 8 The Baha System combines a high performance sound processor, a connecting abutment and a titanium implant.

5 The Baha System consists of three parts: The processor detects sound, cleans, amplifies and transforms it into vibrations. The connecting abutment receives the amplified vibrations and transfers it to the osseointegrated titanium implant. The titanium implant transfers sound vibrations directly to the cochlea via bone conduction Effective By bypassing the outer and middle ear, Baha offers a natural pathway to hearing for people who cannot sufficiently benefit from air conduction hearing aids or who find other bone conduction devices uncomfortable and ineffective. 8 The Baha System combines a high performance sound processor, a connecting abutment and a titanium implant. Titanium is used due to the ability of human bone to integrate with the titanium implant through the unique process of osseointegration, a proven technique that has been used in reconstructive surgery, dental implants and Baha, with great success for more than 3 years. This process enables sound to be conducted directly to the cochlea. Bilateral benefits For candidates with binaural hearing loss, a bilateral fitting of Baha should be considered. This improves speech understanding, sound localization, as well as increasing the personal safety of the patient. 8

Getting a Baha is a straightforward process: The candidate can test the Baha before the surgery. Surgery often takes place in an outpatient setting.

Simple Test and Try Straightforward Procedure Fitting and Fine Tuning Minimal Aftercare A hearing test determines candidate suitability.

Patient is referred to a qualified Baha surgeon. Implant surgery takes place, typically in an outpatient setting.

Settings are adjusted to patient's individual hearing needs manually or through the Cochlear Baha Fitting Software.

These simple tasks include keeping the abutment clean and the sound processor dry.

6 Getting a Baha is a straightforward process: The candidate can test the Baha before the surgery. Surgery often takes place in an outpatient setting. The procedure holds no risk of further hearing loss. Patients can often resume normal activities within a few days. Simple Test and Try Straightforward Procedure Fitting and Fine Tuning Minimal Aftercare A hearing test determines candidate suitability. The candidate can try the Baha using an external test band, test rod or a Baha Softband and experience the potential improvement. Patient is referred to a qualified Baha surgeon. Implant surgery takes place, typically in an outpatient setting. The patient can resume normal activity within just a few days. Once the implant osseointegrates, the Baha Sound Processor is fitted. Settings are adjusted to patient's individual hearing needs manually or through the Cochlear Baha Fitting Software. Patient receives an aftercare kit which provides information about use and care for the Baha System. These simple tasks include keeping the abutment clean and the sound processor dry. TEST BAND IMPLANT PROCEDURE COCHLEAR BAHA FITTING SOFTWARE AFTERCARE KIT Reimbursement Many insurance companies and health care systems reimburse Baha treatment. Contact your local Cochlear office for full details and information. To ensure the best treatment for your patient, contact your local Baha clinic. Here, surgical and audiological specialists collaborate to provide the highest standards of patient care. Contact details for Baha clinics are available at or from your local Cochlear office. 1

Child-Friendly Children with hearing losses face unique challenges with respect to their educational and personal development. Selecting the correct solution should be a carefully considered process.

Selection Correct Device With Cochlear You Have More Choices Indications for Baha for a child are similar to those of an adult.

Timing A child should receive a Baha as early as possible*, in order to facilitate normal development in terms of language and speech comprehension.

7 Child-Friendly Children with hearing losses face unique challenges with respect to their educational and personal development. Selecting the correct solution should be a carefully considered process. With Baha we strive to make this defining decision and the procedure it involves as straightforward as possible for children and parents. Selection Correct Device With Cochlear You Have More Choices Indications for Baha for a child are similar to those of an adult. Very young children can be fitted with the Baha Softband until they are old enough to receive an implant. Timing A child should receive a Baha as early as possible*, in order to facilitate normal development in terms of language and speech comprehension. Counseling The need for counseling in the case of a child is greater than that of an adult. Parents need to be shown how the sound processor operates as well as receive instructions about daily care. Because children may be unable to understand how a sound processor works, device selection is important. Sound processor features that give parental confidence such as tamper resistance, visual confirmation, and FM connectivity are important considerations. Follow-Up Follow-up appointments will be important. For children, fine-tuning the sound processor should be performed more regularly. Choices for Pediatric Patients: Water protection Tamper-proof battery doors Fun colors for battery doors Tamper-proof buttons Visual indicator for processor status Keylock feature Universal Europin accessory connector Safety line More Softband options Joshua, bilateral Baha user Baha Softband gently introducing a new world For children who are not yet ready for an implant*, the Baha Softband is the ideal alternative. Easy to use and comfortable, providing infants and toddlers with the amplification they need to facilitate language development. Consists of soft, elastic headband and plastic snap connector. Holds processor firmly but gently in place. Adjustable fastening facilitates easy pressure adjustment. Easy to shift position, increasing comfort and usefulness when child is in car seat or stroller. Built-in safety release. Baha the experience that matters. No one has more experience of bone conduction hearing solutions than Cochlear. For over 3 years we have dedicated ourselves to researching, developing and applying solutions that can give adults and children the gift of better hearing and we will continue to do so with the same level of commitment in the future. *In the US and Canada, the Baha Implant is indicated for children 5 years and older

Individual Personalized Accessories Audio Adapter Enjoy direct input sound from stereo systems, TVs and MP3 players.

Telecoil * Provides improved hearing over the phone, and in buildings supplied with a loop facility e.g. schools, cinemas. The telecoil sends the signal directly to your Baha.

Our broad product portfolio reflects the needs of a diverse patient base: Cochlear Baha 3 Sound Processor (BP) Premium Performance The Cochlear Baha 3 Sound Processor is world s first programmable

8 Individual Personalized Accessories Audio Adapter Enjoy direct input sound from stereo systems, TVs and MP3 players. FM-Receiver An FM receiver enables the use of most FM systems that are commonly used in school classrooms, improving the hearing performance in noisy environments. Telecoil * Provides improved hearing over the phone, and in buildings supplied with a loop facility e.g. schools, cinemas. The telecoil sends the signal directly to your Baha. Colored Battery Doors ** Every patient is different. Our broad product portfolio reflects the needs of a diverse patient base: Cochlear Baha 3 Sound Processor (BP) Premium Performance The Cochlear Baha 3 Sound Processor is world s first programmable bone conduction sound processor based on a new audiological toolkit dedicated to direct bone conduction. Dedicated signal processing and amplification strategies for direct bone conduction. Developed to take advantage of bone conduction hearing. Fully programmable. Automatic signal processing and automatic noise reduction. Direct Audio Input (DAI) connector. Titanium backing provides durability. Two LEDs provide a visual indication of processor status and settings. Ergonomic operation three button user interface enables quick volume adjustments and uncomplicated program changes. Easily integrate accessories such as FM systems or MP3 players using the standard Europin connector. Cochlear Baha 3 Power Processor (BP) Most Powerful Head-Worn Baha The most powerful head-worn fully programmable sound processor. Ideal for those with a substantial mixed hearing loss, risk of progressive hearing loss and patients with SSD. New directional microphones for better hearing in noisy environment. Same advanced digital signal processing as Baha 3 Sound Processor, provides the best hearing across a variety of sound environments. Thinnest programmable power processor. Automatic noise management. Direct Audio Input (DAI) using the standard Europin connector, easily integrates accessories such as FM systems or MP3 players. COLORS AVAILABLE Cochlear Baha Cordelle II Body Worn Super Power The Baha Cordelle II is the most powerful Baha sound processor, specifically designed to provide maximum power to those with severe mixed hearing losses. Provides a solution in cases of substantial hearing losses. Ensures that even for progressive hearing losses, a Baha solution is available. Body-worn unit for maximum power. Adjustable tone controls. Adjustable trim controls to normalize loud or quiet sounds. Built-in telecoil. NOTE: Not all processors are available in colors shown. Processors not available in all markets. Contact your local Cochlear office for more information. Images not to scale. * Available for the headworn devices only. The Baha Cordelle II has a built-in telecoil for convenience. * * Not available with Cordelle II sound processor. Fitting Range for Baha 3 (BP) -1 Fitting Range for Baha 3 Power (BP) -1 Fitting Range for Baha Cordelle II Nancy, bilateral Baha user 2 3 Bone Conduction Thresholds 2 3 Bone Conduction Thresholds 2 3 Bone Conduction Thresholds dbhl 5 dbhl 5 dbhl Frequency [Hz] Frequency [Hz] Frequency [Hz] 14 Bone-conduction thresholds thresholds 45 db HL 45 averaged db HL averaged across across 5, 5,, 2, and and 3 3 Hz Hz Air-conduction thresholds may extend into this area Air-conduction thresholds may extend into this area Bone-conduction thresholds 55 db HL averaged across 5,, 2, and 3 Hz Air-conduction thresholds may extend into this area Bone-conduction thresholds 65 db HL averaged Bone-conduction thresholds 65 db HL averaged across across 5, 5,, 2, and and 3 3 Hz Hz Air-conduction thresholds may may extend extend into this area into this area

This is the Cochlear promise to you. As the global leader in hearing solutions, Cochlear is dedicated to bringing the gift of sound to people all over the world.

9 This is the Cochlear promise to you. As the global leader in hearing solutions, Cochlear is dedicated to bringing the gift of sound to people all over the world. With our hearing solutions, Cochlear has reconnected over 25, cochlear implant and Baha users to their families, friends and communities in more than countries. Along with the industry s largest investment in research and development, we continue to partner with leading international researchers and hearing professionals, ensuring that we are at the forefront in the science of hearing. For patients receiving any Cochlear hearing system, our commitment is that for the rest of your life we will be here to support you. Act now! Open a Baha clinic or start referring your patients who are potential Baha candidates to your nearest Baha clinic As your patient s partner in hearing for life, Cochlear believes it is important to convey not only the benefits, but also the potential risks associated with a Baha procedure. Not everyone with hearing loss is a candidate for a Baha. Baha is contraindicated in patients with inadequate bone quality or quantity to provide stability and support for the implant, or in patients who will be unable to maintain and clean the skin around the abutment. In the U.S., use of the implanted fixture is also contraindicated in children under age 5 years. All surgical procedures include an element of risk, and it is impossible to guarantee success. The device may fail to osseointegrate for a number of reasons, including physiological and surgical issues as well as traumatic impact to the implant site. On rare occasions the skin around the abutment may become inflamed from a mild infection or the skin may grow back towards its original thickness. For complete information regarding the risks and benefits of a Baha procedure, please refer to the instructions for use for the Baha implant available at Cochlear Americas 1359 East Peakview Avenue Centennial CO 111 USA Tel: Fax: Cochlear Canada Inc 25- Adelaide Street West Toronto, ON M5H 1T1 Canada Tel: Fax: REFERENCES 1 Snik AF, Mylannus EA, Proops DW, et. al. Consensus statements on BAHA system: where do we stand at present? The Annals of Otology, Rhinology & Laryngology 25; 195: Hol MK, Snik AF, Mylanus EA, Cremers CW. Longterm results of bone-anchored hearing aid recipients who had previously used air-conduction hearing aids. Archives of Otolaryngology-Head & Neck Surgery 25;131 (4): Dillon, H. Hearing Aids, New York, Thieme, Lin LM, Bowditch S, Anderson MJ, May B, Cox KM, Niparko K. Amplification in the rehabilitation of unilateral deafness: speech in noise and directional hearing effects with bone-anchored hearing and contralateral routing of signal amplification. Otology and Neurology 26;27(2): Wazen JJ, Spitzer JB, Ghossaini SN, et al. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg 23;129(3): Hol MK, Bosman AJ, Snik AF, Mylanus EA, Cremers CW. Bone-anchored hearing aids in unilateral inner ear deafness: an evaluation of audiometric and patient outcome measurements. Otology and Neurology 25;26(5): Watson GJ, Silva S, Lawless T, Harling JL, Sheehan PZ. Bone anchored hearing aids: a preliminary assessment of the impact on outpatients and cost when rehabilitating hearing in chronic suppurative otitis media. Clin. Otolaryngol. 28, 33, Priwin C, Jönsson R, Hultcrantz M, Granström G. BAHA in children and adolescents with unilateral or bilateral conductive hearing loss: a study of outcome. Int J Pediatr Otorhinolaryngol. 27 Jan;71(1): Flynn MC, Sadeghi A, Halvarsson G. Baha solutions for patients with severe mixed hearing loss. Cochlear Implants Int. 29; 1(S1): Kunst SJ, Hol MK, Snik AF, Bosman AJ, Mylanus EA, Cremers CW. Bone anchored hearing aid in patients with acquired and congenital unilateral inner ear deafness (Baha CROS): clinical evaluation of 56 cases. Doctoral dissertation, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. 28. VELCRO is a registered trademark of Velcro Industries B.V. Baha and Baha Divino are trademarks of Cochlear Bone Anchored Solutions. Cochlear and the elliptical logo are trademarks of Cochlear Limited. Cochlear Bone Anchored Solutions 211. BUN18 ISS2 JUL11

Design concept, technical verification and patient testing of the new Cochlear Baha SoundArc

Design concept, technical verification and patient testing of the new Cochlear Baha SoundArc Before the first implantable Cochlear Baha System was launched, one of the only solutions available to those