Clinician Resource Guide

Transcription

1 Clinician Resource Guide

2 Table of Contents Sanctuary Fitting Criteria and User Protocol... 3 Coding and Insurance Suggestions... 6 Accessing the Clinician Menu... 7 Headphone Selection... 8 Hearing Profile Selection... 8 Warranty... 9 Terms and Conditions of Sale Order Form Patient Expectation/Fitting Agreement

3 Neuromonics Sanctuary Fitting Criteria and User Protocol Product Overview Targeting immediate relief for the tinnitus patient with a TRQ score of 35 or below, the Neuromonics Sanctuary is engineered to provide relief for patients while listening to the device. Incorporating a Phase One Neuromonics Stimulus, the Sanctuary provides a sense of control by delivering a customized signal designed for maximum interaction with the tinnitus perception. This interaction provides an almost immediate sense of control and relief for the tinnitus patient. Neuromonics Phase One Stimulus The Sanctuary is pre- programmed with four musical tracks containing the Phase One Neuromonics Stimulus. The underlying principle is to provide a high level of interaction for the patient while listening, thus providing an immediate sense of control and relief over the tinnitus perception. Candidacy Candidates for the Neuromonics Sanctuary are individuals with a complaint of tinnitus that are seeking a management program as opposed to a treatment protocol. Ideally this will be someone with a TRQ score of 35 or below. The Neuromonics Sanctuary will use a semi- custom version of the Neuromonics Oasis stimulus that is appropriate for one of the three fitting ranges pictured below. You will choose the fitting range that best matches your patient s audiogram. Neuromonics recommends that approximately 75% of your patient s audiometric thresholds fall within the fitting range of the specified audiogram. If your patient is outside of a fitting range, then it is left to the clinical judgment of the clinician to choose the most appropriate range. Attention must be paid to adequate stimulation when choosing the most appropriate fitting range. Device Usage Patients are recommended to wear their device when their tinnitus is bothersome. Patients should use the device at a volume that is comfortable while providing the maximum relief from their tinnitus. Patients are advised to turn the volume down in advance of ending a listening session. They should also avoid removing the device in an environment that is quiet. Patients should not use their device when straining to hear, when exercising, while driving, watching television with sound, while wearing a hearing aid or when the device may get wet. 3

4 Audiometric Guidelines: Fitting Profile 1 Fitting Profile 2 Fitting Profile 3 Fitting Profile 1 is for normal hearing, or normal hearing sloping to a mild, high frequency symmetrical hearing loss. Fitting Profile 2 is for normal hearing sloping to a mild through moderately severe, high frequency symmetrical hearing loss. Fitting Profile 3 is for normal hearing /mild hearing loss sloping to a moderately severe through severe, high frequency symmetrical hearing loss. In addition to the hearing profile choices above, patients should meet the following criteria: TRQ score of 35 or below Disturbance and awareness, in general, should be below 50% No apparent Psychological Disturbance. Patient must score a 0 on TRQ question #24 No apparent indication of reactive tinnitus Quality of Life Indicators Patients that experience difficulty before bed and during quiet times; such as while reading or working on a computer are good candidates for the Sanctuary. Also, if concentration is a problem this protocol is appropriate. The Sanctuary is designed to provide relief for patients during times when their tinnitus is disturbing. Device Fitting/ Assessment Assessment/ Fitting Appointment: You should continue to use your standard tinnitus assessment including testing for Residual Inhibition to identify potential cases of reactive tinnitus. Given the pre- configured set- up of the Sanctuary, patients can be fit the same day in your office. Topics to cover during the fitting include: o Device Instruction 4

5 o o o o Expectation counseling Establish patient goals and appropriate device usage Review Tinnitus Management Handbook Determine interaction and relief levels Contained within the Clinician Menu are the following items that must be selected: o Headphone choice (Sony MDR- ED12LP is the default option and is included with Sanctuary) o Hearing profile selection Remember to use the Clinician Quick Reference Guide for help navigating the Clinician Menu. Headphone Selection The Neuromonics Sanctuary will include Sony MDR- ED12LP headphones. The unit will come programmed with this headphone selection. One additional headphone options is also available for the Sanctuary at an additional charge: o Bose IE2 - $99 * Speaker Accessory Available as a bedside accessory to aid in sleep onset, the JBL On Tour Micro can be purchased for an additional $45. The JBL Micro connects via a self- contained 3.5mm headphone jack. *If an additional set of headphones is ordered, then the appropriate change must be made in the headphone selection menu when setting up the device. Follow Up Protocol No specific follow up protocol is required for Neuromonics Sanctuary patients. Subsequent office visits are based on the needs of the patient and the discretion of the fitting clinician. If such visits are warranted, particular attention to the following items are suggested: o o Make sure patient goals for relief are being met while wearing device. Review realistic expectations and discuss additional options if patient is not experiencing relief. 5

6 Supplemental Materials In addition to the programmed Oasis device, patients will receive supplemental material to help them with tinnitus management strategies. These materials include: Neuromonics Sanctuary Tinnitus Management Handbook Patient Quick Reference Guide Coding and Billing Suggestions Below you will find commonly used codes for tinnitus related audiometric evaluations. Code Procedure 2012 Medicare Rate Tympanometry $ DPOAE's $ Comprehensive Audiometry $ Assessment of Tinnitus (*Pitch Match *Loudness Match *MML) $68.76 Total $ Durable Medical Equipment (E1399) According to most insurance providers, Durable Medical Equipment meets the following criteria: Ordered or provided by a Physician for outpatient use primarily in a home setting. Used for medical purposes. Not consumable or disposable except as needed for the effective use of covered Durable Medical Equipment. Not of use to a person in the absence of a disease or disability. Based on this definition, the Sanctuary may be considered DME. Historically, the Neuromonics Oasis has had limited insurance coverage under the DME provision; most likely due to the cost of the Oasis exceeding the typical DME coverage cap of $2500 to $3500 per calendar year. The Sanctuary falls well below this annual cap and may yield better insurance coverage for your patients. 6

7 Additionally, the Sanctuary falls under the current 510k FDA Clearance as the Neuromonics Oasis thereby providing additional credibility to the claim. Summary The Neuromonics Sanctuary is designed to help the mild to moderate tinnitus sufferer experience relief from their tinnitus disturbance while wearing the device. The Sanctuary is not designed to replace the Neuromonics Tinnitus Treatment or to treat the severely disturbed tinnitus patient. The Sanctuary is designed to offer relief and tinnitus management options for your patients. Management expectation, as with all tinnitus treatment options, will be integral to the overall success of the management program. The expectation should be set that patients will typically only experience relief while wearing their Sanctuary device. The management program is centered on providing situational relief from the tinnitus perception. By using the Sanctuary in specific situations such as going to bed, when reading or in quiet times, the user will gain a sense of control and relief over their tinnitus. As always, please contact your Neuromonics Clinical Specialist if you encounter difficult patients or have any questions regarding the appropriateness of a particular patient. Accessing the Clinician Menu In the Clinician menu, you can change the headphone type and change the hearing profile. These should only be adjusted under the supervision of your clinician. The passcode required to enter this menu has been provided to the clinician. To access the Clinician menu for advanced features: Press and hold the center Play button for approximately 3 seconds to access the set- up menu. To access the Clinician Menu, press the +/- buttons until the Clinician Menu is highlighted. Press the Center button to access the Clinician menu. Enter Password will appear on the screen The Clinician Menu is locked so you must press the following buttons in order to enter the menu: center, right arrow, left arrow, + (up), then - (down) 7

8 Headphone Selection Using the +/- buttons, highlight the Headphones section. To change the type of headphone press the << or >> buttons until the desired headphone is selected. Hearing Profile Selection Using the +/- buttons, highlight the Headphones section. To change the hearing profile press the << or >> buttons until the desired profile is selected. To set the date and time: Press and hold the Play button until the set- up menu appears (approx 5 seconds). Using the +/- buttons, scroll down until the Set Date/Time Menu is highlighted. Press the center Play button to access the Date/Time Menu In the Date field press the +/- keys until the desired month is selected. By using the << and >> buttons, you can move to the Day field and repeat step number 4 to achieve the desired day. 8

9 Warranty Coverage The Neuromonics warranty period is 12 months from the fitting date as declared on the Warranty Registration Card. Please ask the patient to complete this registration at the time of fitting. Please complete the warranty registration form online at Failure to submit a warranty registration could result in breach of warranty. Neuromonics Sanctuary Warranty Covers all Manufacturers defects for a period of twelve (12) months. Headphone Warranty Neuromonics will honor the manufacturers warranty on the prescribed headphones for the Sanctuary. Neuromonics will process headphone replacements through our CFC system. Replacement headphones will be limited to one (1) pair during the appropriate warranty period. All necessary forms are available on Extended Warranty Coverage For $139, an Extended Warranty can be purchased through Neuromonics, Inc. Coverage can be purchased no later than 30 days after the fitting of the device and will cover user damage that renders the device inoperable. Coverage is limited to one replacement device in a thirty-six (36) month period. For $199 coverage will cover loss and damage of the Sanctuary that renders the device inoperable. Coverage is limited to one replacement device in a 36-month period. Replacement devices will be returned to patient/clinic via FedEx Ground service. Patient/Clinic is responsible for returning damaged device to Neuromonics. Upon receipt of damaged device, Neuromonics, Inc will replace the damaged device and return to patient/clinic via FedEx Ground service. Extended Warranty coverage will be tracked via the Warranty Registration process that must be completed at Failure to submit Warranty Registration will void device coverage. Extended Warranty MUST BE PAID IN FULL FOR COVERAGE TO BE VALID. 9

10 Neuromonics Sanctuary Terms and Conditions of Sale 1. General 1.1 These Terms and Conditions of Sale constitute an integral part of any offer made by Neuromonics, Inc. ( Neuromonics ) to sell the Sanctuary ( Product ) to the purchaser and shall govern the sale of the products. 1.2 An Order by Purchaser shall not be binding upon Neuromonics, Inc until Neuromonics has completed a credit review and has accepted the order in writing (which may include ). A purchase order shall constitute and acceptance of all of these Terms and Conditions of Sale despite any additional or different terms proposed in the purchase order and shall form an agreement for the purchase of products from Neuromonics (the Agreement ). 2. Prices 2.1 Prices to be paid for the products by Purchaser are set forth on the invoice. 3. Terms of Payment 3.1 Terms are net thirty (30) days from the invoice. 3.2 Purchaser shall pay Neuromonics interest at the rate of one and one-half percent (1.5%) per month or the highest rate permitted by applicable law, whichever is lower, on all invoices past due. Purchaser agrees to pay all reasonable attorneys fees and expenses incurred by Neuromonics enforcing it rights hereunder. 4. Delivery and Inspection 4.1 Delivery and completion schedules are approximate only and are based on conditions at the time of acceptance of Purchaser s order. 4.2 Transportation shall be by a common carrier, at Neuromonics risk and expense. Neuromonics will select the method of shipment and the carrier. 4.3 Purchaser shall inspect all goods upon arrival and shall give written notice to Neuromonics, Inc., within ten days of arrival, any claim for shortage or other nonconformance with the terms of Purchaser s order. If Purchaser fails to give timely notice, all goods shall be deemed to conform to the Purchaser s order. 10

11 5. Changes and Cancellation 5.1 Orders for products accepted by Neuromonics are not subject to change or cancellation by Purchaser except with Neuromonics, Inc prior written consent. All sales are final. 5.2 Neuromonics shall have the right to change the manufacture and/or design of its products if the, in the judgment of Neuromonics, Inc such change does not alter the general function of the products. 6. Return Policy 6.1 In the event a patient is not satisfied with the Neuromonics, Inc product during the first forty five (45) days from the fitting date, the product may be returned to Neuromonics, Inc and Neuromonics, Inc will refund to Purchaser the price paid for the product, less a $95 return fee. The product must be accompanied by Neuromonics, Inc Complaint/Return Form, must be returned to the location designated by Neuromonics, Inc for such returns and must be returned in good working condition, ordinary wear and tear excepted. 7. Force Majeure 7.1 Neuromonics will make every effort to complete the shipment when indicated, but shall not be liable for any loss or damage for the delay in delivery due to causes beyond its reasonable control, included to but not limited to, acts of God, acts of government, strike, lockout, compliance with any governmental rules or regulations or shipping problems. Should such a delay occur, Neuromonics may reasonably extend delivery or production schedules, or at its option, cancel the order in whole or part without liability other than to return any unearned deposit or prepayment. 8. Limited Warranty 8.1 Neuromonics extends this Limited Warranty to the original end-use purchaser of the Neuromonics Sanctuary or the person receiving a Product as a gift, provided that the Neuromonics Product was purchased from an Authorized Provider as defined below. The Limited Warranty does not extend to any other person or transferee. Statutory or common law may provide additional rights or remedies that vary from state to state, and country to country, which does this Limited Warranty not affect. 8.2 DEFINITIONS 11

12 8.2.1 "Authorized Provider" means any trained, approved physician or audiologist that was duly authorized by Neuromonics at the time of the sale to sell authentic Neuromonics products in the jurisdiction where it sold the Product, and that sold the Product in new, unused condition in its original packaging Fraud or Misrepresentation means misrepresenting any fact related to a warranty claim to Neuromonics, including the nature of the defect, whether the Product was purchased from an Authorized Dealer, and the authenticity of the Product. Any representation of a claimed Manufacturing Defect that was known to be caused completely or partially by (a) any use other than Intended Use, (b) transportation, neglect, misuse or abuse by anyone other than Neuromonics employees, (c) alteration, tampering or modification of the Product by anyone other than a Neuromonics employee, (d) accident (other than a malfunction that would otherwise qualify as a Manufacturing Defect), (e) maintenance or service of the Product by anyone other than a Neuromonics employee or agent, (f) exposure of the Product to extreme heat, bright light, sun, liquids, sand or other contaminants, or (g) acts outside the control of Neuromonics, including without limitation acts of God, fire, storms, earthquake or flood, is considered fraud Intended Use means use of the Product (a) within a home or dwelling, (b) for private (as opposed to commercial) purposes, (c) in conformity with all applicable local, state or federal law, code or regulations (including without limitation building and/or electrical codes), (d) in accordance with Neuromonics recommendations and/or instructions in the materials and documentation that accompany the Product, and (e) if applicable, with proper electrical grounding. 9. SCOPE OF LIMITED WARRANTY Neuromonics provides a Limited One Year (365 days) Warranty against Manufacturing Defects for the Sanctuary. If the Sanctuary contained a Manufacturing Defect when it was purchased from an Authorized Provider, Neuromonics, at its sole discretion, will (i) repair, (ii) replace, or (iii) provide a Warranty Credit for the Sanctuary. The amount of the Warranty Credit shall be equal to the purchase price of the Sanctuary paid to the Authorized Provider. Neuromonics reserves the right to inspect any Product subject to a warranty claim to determine, at its sole discretion, whether the claimed defect is a Manufacturing Defect or otherwise. All Warranty Credits and Aggressive Listener Credits may be used only toward the purchase of the Neuromonics Sanctuary. 12

13 9.1.2 NEUROMONICS DOES NOT ASSUME ANY LIABILITY FOR ANY INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES UNDER THIS LIMITED WARRANTY. 10. TERMS AND CONDITIONS In the case of fraud or misrepresentation, Neuromonics, Inc reserves the right to deny all warranty coverage or claims. Risk of Loss- Neuromonics is not responsible for any reason if the Sanctuary is lost in shipping and not actually received by Neuromonics. To avoid unnecessary delays and minimize the possibility of a lost the Sanctuary we strongly suggest that you use the return label provided to you by Neuromonics. No warranty will be provided for any Sanctuary not actually received by Neuromonics. 11. CHOICE OF LAW/JURISDICTION This Limited Warranty and any disputes arising out of or in connection with this Limited Warranty ("Disputes") shall be governed by the laws of the State of Colorado, USA, excluding conflicts of law principles and excluding the Convention for the International Sale of Goods. The courts located in the State of Colorado, USA shall have exclusive jurisdiction over any Disputes. 12. OTHER RIGHTS THIS LIMITED WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE AND JURISDICTION TO JURISDICTION, AND WHICH SHALL NOT BE AFFECTED BY THIS LIMITED WARRANTY. THIS WARRANTY EXTENDS ONLY TO YOU AND CANNOT BE TRANSFERRED OR ASSIGNED. If any provision of this Limited Warranty is unlawful, void or unenforceable, that provision shall be deemed severable and shall not affect any remaining provisions. In case of any inconsistency between the English and other versions of this Limited Warranty, the English version shall prevail. 13

14 ORDER FORM NEUROMONICS SANCTUARY Clinic Name Date Address Zip Code Contact Name Phone Number ( ) - Neuromonics Sanctuary Delivery Requirements (Includes Sony MDR-ED12LP Headphones) Single Units $655 each # ` Date required: / / 2-5 units 6-19 units $585 each # $575 each # Please allow 7 business days from the date the order is submitted to Neuromonics until the date required. 20+ units $550 each # Rush Order Additional Options BOSE IE2 Earphones (Add $99 per pair) For orders required in less than 5 business days, check the Rush Order box. A $50 fee will be applied to all Rush Orders. JBL Micro Speaker (Add $45 each) Order Total $ 14

15 Neuromonics Sanctuary Patient Expectation/ Fitting Agreement Patient Name Date Based on your TRQ score of, are not considered an appropriate candidate for the Neuromonics Sanctuary. Based on your TRQ score of, are considered an appropriate candidate for the Neuromonics Sanctuary. The Sanctuary is: The Sanctuary is not: A tinnitus management tool Designed for relief while listening A medical device A cure for tinnitus A long term treatment program Appropriate for all types of tinnitus and/or levels of hearing loss I should use the Sanctuary: In quiet times When my tinnitus is bothersome While attempting to fall asleep I should not use the Sanctuary: When driving While watching TV or straining to hear While exercising 15 Doc. No CL Revision 1

16 The following conditions can limit the effectiveness of the device: o Asymmetrical Hearing greater than 20db between ears o Answer other than 0 on TRQ question 24 o TRQ score greater than 35 o Significant history of depression/anxiety/disturbance associated with your tinnitus o A tinnitus disturbance level requiring a treatment protocol and follow-up program as opposed to a management tool. As part of my tinnitus management program I agree to: Listen to my Sanctuary at the appropriate times and at a comfortable volume level Take steps to mitigate other factors that negatively impact my tinnitus Consult my clinician if I feel my tinnitus is worsening The benefits I can achieve by using the Sanctuary appropriately are: Control over my tinnitus Relief while listening Help with concentration Help with relaxation I,, understand that I am / am not considered a candidate for the Neuromonics Sanctuary based on the evaluation of my audiologist. As a result I would like to purchase the device in anticipation of any benefits it may provide. Doc. No CL Revision 1