Surgical Hearing Implant Program Otolaryngology ANNUAL REPORT 2012-2013 Department Name
1 Executive Summary Vision To enrich communication and quality of life for Manitobans by delivering safe, accessible and innovative hearing solutions. Mission To establish a nationally recognized surgical hearing implant centre through collaborative research, evidence-based practice and state-of-the-art technology. Summary This report will outline the current status of the Surgical Hearing Implant Program (SHIP) of the department of Otolaryngology Head & Neck Surgery at Health Sciences Centre (HSC) as of March 31 st, 2013. The report will provide information on the status of the bone anchored hearing aid (BAHA) program and the cochlear implant (CI) program, including patient demographics, audiometric/candidacy information, financial statements and the projected plan for program development in the upcoming fiscal year. The BAHA program achieved 78% (11/14) of its annual implant quota for the 2012-2013 fiscal year. Eleven adult patients (average age: 60 years) were implanted unilaterally and fit with an external processor. There are currently 9 patients awaiting implant surgery and 60 patients awaiting trial for candidacy. Assuming approximately 40 of those patients will meet candidacy criteria, the waiting list for BAHA implantation will exceed 3 years at current quota levels of 14 per year. The BAHA program exceeded its annual budget the past fiscal year, despite not meeting quota. However, these costs were offset by savings achieved through the CI program and did not affect patients. The Cochlear Implant program achieved 97% (34/25) of its annual implant quota for the 2012-2013 fiscal year. The program completed 29 surgical procedures on 21 adult and 8 pediatric patients, including 4 pediatric patients who were implanted bilaterally. There are currently 8 patients preparing for CI surgery and approximately 52 patients who have passed audiological candidacy criteria and are awaiting consultation with physicians, resulting in an approximate 2-year waiting list for implantation. The cochlear implant program achieved 95% of its annual budget and saw a reduction in the average implant cost of approximately $2,500 due to completion of primary and secondary vendor contracts in the 3 rd quarter. Entering the third fiscal year and first full year with a dedicated coordinator on staff, both BAHA and CI programs require more work to streamline patient flow and maintain consistent levels of ancillary support. However the work of many dedicated individuals has allowed the Surgical Hearing Implant Program to come very close to meeting annual quotas while still operating within budget in order to provide Manitobans with state-of-the art hearing implant technology in an evidenced-based delivery model. It is the goal of the program to continue improving processes in order to create a consistent and manageable surgical schedule that will decrease stress on the entire system while still maximizing beneficial outcomes for patients. This will be accomplished through inter-disciplinary research, dedicated personnel and collective teamwork to ensure patients in Manitoba receive the quality of care they expect and deserve.
2 Contents Executive Summary... 1 Contents... 2 1. BAHA Program Summary... 3 2. Cochlear Implant Program Summary... 7 3. Future Program Development... 11
3 1. BAHA Program Summary 1.1 Current BAHA Program Status The BAHA program has a current caseload of approximately 167 participants with 30 of those patients using some form of osseointegrated device. 32% of these patients were implanted outof-province prior to program initiation (or were simply absorbed into the program by migrating permanently to Manitoba from other regions) while 59% were implanted in-province since 2010. Finally, 9% of patients use the processor in conjunction with a soft-band and did not undergo surgery for implantation. Since the inception of the program, a total of 10 patients have been implanted in Manitoba between 2010 and 2011 and 8 patients have been implanted in the current fiscal year (01/04/2012 ). There are currently 11 patients awaiting surgery for implantation and 58 awaiting a consultation/trial with audiology. Approximately 33 patients have undergone a trial period and declined to proceed with surgery. Table 1 (below) specifies the number and designation of each patient category. Total number of patients involved in the program 162 Number of patients implanted in province (prior to current fiscal year) 10 Number of patients implanted out of province (prior to 2010) 11 Number of patients implanted in the current fiscal year (1-4-2012 / 31-03-2013) 11 Number of patients using devices with soft band (non-implanted) 3 Total number of patients currently fit with implanted devices: 30 Number of patients awaiting implantation surgery for current fiscal year 12 Number of patients awaiting trial/consultation with audiologist 52 Number of patients seen for consultation who did not meet candidacy requirements 33 Table 1. Overview of current BAHA patient status. 1.2 Patient Demographics: Mixed-Conductive Hearing Loss Individuals with Mixed-Conductive hearing loss comprise 93% of all implanted patients in the program. Patients range in age from 33 to 78 years with a mean age of 54. Figure 1 (below) represents the average audiogram for this patient group. On average, patients in the Mixed- Conductive hearing loss group present with flat, moderate to moderately-severe air conduction thresholds and slightly sloping, normal-to-mild bone conduction thresholds. The average airbone gap, per frequency (Figure 1) is consistent with BAHA candidacy for this type of hearing loss.
4 Figure 1. Average audiogram for Mixed-Conductive hearing loss group. 1.3 Patient Demographics: Unilateral Sensorineural Hearing Loss (Single Sided Deafness) At this point in the program, individuals with unilateral sensorineural hearing loss ( Single Sided Deafness ) comprise 17% of all implanted patients. Patients in this category range in age from 64 to 76 years with a mean age of 70. Figure 2 (below) represents the average audiogram for this patient group. On average, patients with unilateral sensorineural hearing loss present with flat, profound air conduction thresholds in the poorer ear and mild-to-moderate air/bone conduction thresholds in the better ear. Bone conduction thresholds for the poorer ear in this group exceeded the maximum output limits of the testing equipment. Figure 2. Average audiogram for Unilateral Sensorineural hearing loss group.
5 1.4 BAHA Program - Financials for 2012-2013 Fiscal Year A total of 11 patients were unilaterally implanted this fiscal year, enabling the program to come close to reaching the annual quota of 14 implants. See Table 2 (below) for all implanted patients in the BAHA program from this fiscal year as well as patients who have successfully completed the BAHA trial and are awaiting the procedure. Table 2. Cost per BAHA surgery for current fiscal year. The cost structure for all osseointegrated devices are listed in Table 3 below. The funding for BAHA type instruments are separated into 2 categories: (1) implant with abutment and (2) external processor. With an annual quota of 14 BAHA implants, the estimated cost for implantation and external device was originally $5,500, for a total of approximately $77,000. However, the original estimate was low as the actual cost per implant is approximately $6,500 (Table 3). Part of the reason for this discrepancy was the absence of finalized vendor contracts prior to the launch of the program. As a result, the cost of the implant and external processor exceeded expectations for both primary and secondary vendors. In addition, despite not reaching its annual quota of implants, the BAHA program exceeded its budget for this fiscal year by approximately $22,604. The reason for this overrun was that the funding estimate also neglected to account for needed inventory for each procedure as the length and diameter of the implant may vary per patient based on factors present during surgery. However, due to savings achieved on the cochlear implant budget, the program was able to absorb this added cost without reducing services for patients. Looking forward to the upcoming fiscal year, negotiations will take place with vendors to arrange consignment for necessary inventory in order to avoid this same impact on the next budget.
6 Fiscal Year: 2012-2013 Month Number of Surgeries/Implants Funding for BAHA Surgery April 1 $6,384 June 1 $6,865 August 1 $6,175 September 1 $6,715 October 1 $6,715 November 1 $6,115 January 1 $6,327 February 1 $6,327 March 3 $18,981 Inventory - $19,000 Table 3. BAHA patients, current fiscal year. Total: $99,604 Projected: $77,000 Variance: ($22,604) Average Cost Per Surgery: $6,453 1.5 BAHA Waiting List Management The program receives approximately 8 physician referrals per month, resulting in 60 patients currently on the waiting list for a BAHA trial. A fully operational BAHA program should be able to facilitate 4 new BAHA trials per week using a week-long trial structure. Under this system (accounting for the new referrals each month), the BAHA program should be able to eliminate the waiting list for new trials within approximately 16 weeks to facilitate wait times of no longer than one month per patient. Figure 3. Projected time frame for reducing BAHA waiting list.
7 2. Cochlear Implant Program Summary 2.1 Cochlear Implant Program Status The Cochlear Implant program has a current caseload of approximately 42 active participants currently implanted and approximately 50 patients awaiting surgery. In the first year of the program (2011-2012), there were 12 surgeries completed using a total of 12 implants. The current fiscal year (2012-2013) has seen 29 surgeries completed using 34 implants. 86% of active patients were implanted with a unilateral implant while 14% of patients utilize bilateral implants (all bilateral implants were pediatric patients). Patients from across Manitoba have undergone surgery for implantation; however the majority of recipients reside within 100 kilometers of Winnipeg (Figure 4). Figure 4. Geographical location of all Manitoban cochlear implant recipients. 2.2 CI Patient Demographics: Adults Adult patients range in age from 33 to 85 years with a mean age of 60.2. On average, patients present with flat, severe-to-profound audiometric configurations, although there are a few exceptions where some usable hearing in the low frequencies is demonstrated. Figure 5 (below) represents the average audiogram for this patient group as well as the average aided hearing thresholds as measured in sound field through the cochlear implant.
8 Figure 5. Average unaided/aided audiogram for the adult patient group. 2.3 CI Patient Demographics: Pediatrics Pediatric patients range in age from 18 months to 6 years with a mean age of 3.5. On average, patients present with flat, severe-to-profound audiometric configurations. Figure 6 (below) represents the average audiogram for this patient group as well as the average aided hearing thresholds as measured in sound field through the cochlear implant. Figure 6. Average unaided/aided audiogram for the pediatric patient group.
9 2.4 CI Outcome Measures Aided benefit with the cochlear implant is evaluated by testing the patient s ability to correctly identify speech in the form of phonemes, words and entire phrases in both quiet and with competing noise. The entire test battery for cochlear implant users can be referenced here, but the tests presented for this report include: Consonant-Nucleus-Consonant (CNC) Test Hearing in Noise Test (HINT) AzBio Test (Arizona State University) Standardized speech recognition testing is used to measure the objective benefit each patient receives from their implanted device. Patients are placed in a sound-treated booth and asked to repeat consonant sounds, word and phrases at threshold and supra-threshold levels with and without competing broadband noise. Patients are typically tested in a number of conditions which include unaided (without the use of either cochlear implant or conventional hearing aid), and aided with cochlear implant only. The ability of the patient to accurately identify and repeat speech stimuli is expressed as a percent correct score in Table 4 (below). The average results indicate a net increase in the ability to correctly identify speech using the cochlear implant ranging from 32% to 57%, depending on the test. Table 4. Average speech reception test results: unaided (gray columns) and aided (green columns).
10 2.5 CI Program - Financials for 2012-2013 Fiscal Year The monthly cochlear implant surgeries for the past fiscal year are illustrated in Figure 7 (below) in order to examine trends in surgical procedures and to help improve efficiencies within the process. Figure 7 demonstrates where periods of activity existed during the last fiscal year, followed by brief periods of higher levels of activity weighted towards the end of the year. This creates stress on the system and affects all parties involved with regard to finding available OR time for surgeons, prepping and booking patients for surgery, maintaining appropriate surgical supplies on short notice, tracking patient flow and creating consistent budgeting expectations. Looking forward to the next fiscal year, one of the goals of the surgical hearing implant program will be to create a consistent patient flow that results in approximately 3 cochlear implant surgeries per month. This will help reduce variability in the process, eliminate uncertainty and ease burden on surgeons and OR resources, while still meeting the annual quotas for implants. Figure 7. Number of Cochlear Implant procedures/implants per month during 2012-2013 fiscal year. Budget The funding for cochlear implants is separated into 2 categories: (1) internal implant with electrode array and (2) external speech processor. With an annual quota of 35 cochlear implants, the estimated cost for implantation and external device is $30,000, for a total of approximately $1,050,000 allotted for the cochlear implant portion of the surgical hearing implant program. The program has a working relationship with 3 individual cochlear implant manufacturers which results in a different surgical and equipment cost for each procedure. Due to primary and secondary vendor contract deductions, the actual average cost per cochlear implant surgery is approximately $30,705 and the average cost per implant was $26,190. The cost structure for internal implant and external processor for each vendor is listed in table 5 below. Vendor Internal Implant External Processor Total Med-El $16,973 $8,487 $25,460 Cochlear $25,358 $5,699 $31,057 Advanced Bionics $13,781 $8,978 $22,759
11 Fiscal Year: 2012-2013 Month Surgeries Implants Ordered Funding April 2 2 $56,052 June 3 3 $79,276 August 3 4 $114,423 September 3 4 $109,538 October 1 1 $22,759 November 4 4 $107,632 December 4 4 $93,737 January 4 4 $91,036 February 4 6 $170,482 March 1 2 $45,518 Total: 29 34 $890,453 Projected: 35 35 $1,050,000 Variance: (6) (1) $172,407 Average Cost per Surgery: $30,705 Average Cost per Implant: $26,190 Table 5. Cost per cochlear implant procedure for current fiscal year. Vendors The surgical hearing implant program has cultivated partnerships with three different cochlear implant vendors, including Med-El, Cochlear Corporation and Advanced Bionics. The primary vendor contract was awarded to Advanced Bionics and was finalized in October 2012 while the secondary contract was awarded to Cochlear in November 2012. To meet the contract obligations, the program must dispense approximately 60% Advanced Bionics product and approximately 30% Cochlear product per year. These contracts allowed the program to reduce the average cost of each cochlear implant by approximately $2,500. Since these contracts were ratified towards the end of the fiscal year, 3. Future Program Development 3.1 Program Plan for Next Fiscal Year It is the goal of the surgical implant coordinator to provide a detailed protocol around the CI program in order to streamline existing hospital processes, create a national evidenced-based centre for excellence and to offer patients a consistent and positive experience throughout their relationship with HSC. In order to achieve these goals, the CI program will begin to implement the following over the next 12 months: Create a consistent system that facilitates 3 CI surgeries per month, every month. Determine a streamlined system for patient referral, device ordering and tracking costs. Create a comprehensive patient information packet detailing all the steps from diagnosis to device activation. Establish consistent clinic schedules for cochlear implant patient fittings and follow up Create a consistent set of measurable outcomes to assess benefit for the patient and justify funding for the program
12 Create an informative and interactive internet presence for patients and professionals Collaborate with other implant programs across the country in order to ensure best practices are in place Collaborate with local professionals to ensure transparency and open communication for patient benefit Reduce patient waiting lists for surgery and cochlear implant consultation Apply for provincial and federal grants for additional funding for research Justyn Pisa AuD, Coordinator Surgical Hearing Implant Program Department of Otolaryngology Head & Neck Surgery jpisa@hsc.mb.ca