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Related Manuals for MED-EL Bonebridge SAMBA 2
Summary of Contents for MED-EL Bonebridge SAMBA 2
- Page 1 Business Unit Vibrant SAMBA 2 Audio Processor English WM166573_0 Dokumentenbox: 155x213 1.5x Sichtfenster: 135x28 Positionierung Dokumentenbox für Vorschau Aussparung –3,5 –1,5 7.5x...
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Page 3: Table Of Contents
Instructions for use Table of contents Contents of the package ................... 3 2. Introduction ......................4 3. General information ....................5 Device description ......................5 SAMBA 2 Audio Processor overview ..................6 Intended use – Indications – Contraindications ..............7 Intolerances ........................7 4. User information ....................... 8 Switching SAMBA 2 on/off ....................8 Placing SAMBA 2 over the implant ..................9 Changing program and volume .................. - Page 4 7. Warnings and precautions ..................26 Warnings ..........................26 Precautions ........................27 Possible adverse events associated with Bonebridge surgery ........28 Interference with other equipment .................29 Initial activation ........................31 8. Clinical summary ....................32 9. Miscellaneous......................63 Technical data ........................63 Warranty statement ......................65 Symbols ..........................65 Radio frequency/Telecommunication information............66...
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Page 5: Contents Of The Package
Contents of the package 1. Contents of the package • SAMBA 2 Audio Processor • Daily case • Set of batteries • Set of interchangeable covers • Attachment clips for hair and clothes • Accompanying documents... -
Page 6: Introduction
Introduction 2. Introduction These instructions for use cover the use of the SAMBA 2 Audio Processor. You should read the instructions for use carefully and completely so that you are famil‑ iar with the operation and maintenance of your audio processor. Please do not hesitate to contact your audiologist/healthcare professional, clinic or MED‑EL representative with any additional questions you may have. -
Page 7: General Information
General information 3. General information Device description The Bonebridge system consists of two major components: the osseointegrated implant, called Bonebridge Bone Conduction Implant (BCI), and the externally worn audio processor. The externally worn audio processor is attached to the user’s head, behind the ear. A magnet in the audio processor is attracted to an opposing magnet within the implant. -
Page 8: Samba 2 Audio Processor Overview
General information SAMBA 2 Audio Processor overview Microphone openings ① Indicator relevant for users with two implants ② = right side, = left side) Magnet ③ Interchangeable cover ④ Battery compartment ⑤ Air vents ⑥ Bracket groove (recess for attachment clip fixation) ⑦... -
Page 9: Intended Use - Indications - Contraindications
General information Intended use – Indications – Contraindications Intended use The SAMBA 2 Audio Processor is an external part of the Bonebridge system. The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting or single-sided deafness. The Bonebridge augments hearing by providing acoustic information to the inner ear via bone conduction. -
Page 10: User Information
User information 4. User information Switching SAMBA 2 on/off Open the battery compartment about 5 mm (3/16 in) to switch the SAMBA 2 off. Always open the battery compartment whenever the audio processor is not in use to extend the life of your device’s battery. PARENTAL GUIDANCE ��... -
Page 11: Placing Samba 2 Over The Implant
User information Placing SAMBA 2 over the implant This side up Implant system activated The audio processor is kept in position over the implant by magnetic force. Your audi- ologist/healthcare professional can exchange the magnet of the audio processor to a different strength for your best benefit. -
Page 12: Changing Program And Volume
Adjust of volume of masking signal • Check battery status of the audio processor • Mute ― 1 The SAMBA 2 Remote app may not be available in some countries. Contact your audiologist/healthcare professional or your local MED-EL representative for specific information. -
Page 13: Battery Status
User information NOTE: The app only works in one direction and does not receive any information from the audio processor. When switching on, the audio processor automatically starts in the Universal‑program (Program 1) and with default volume, whereas the app shows the last chosen program and volume slider position. - Page 14 User information To change the battery, follow these steps: Remove used battery ① ② Insert new battery ③ ④ ⑤ ⑥ NOTE: It is recommended to peel the protective film off the battery one to two minutes before battery insertion. This time is needed for the zinc‑air battery to charge up completely.
- Page 15 User information Spare battery It is recommended that you always carry a spare battery in its original packaging with you. Disposal of battery Always remove the used battery immediately to avoid battery leakage and possible dam- age to the audio processor. To avoid environmental pollution, do not throw batteries into household trash.
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Page 16: Changing The Cover
User information Changing the cover Different covers can be used to change and customize the appearance of your SAMBA 2. NOTE: If the cover is broken or the membranes underneath the microphone openings are damaged or clogged, the cover must be exchanged. CAUTION ⚠... -
Page 17: Using The Attachment Clips
User information Using the attachment clips Attachment clips are provided for additional fixation of the audio processor to your hair or clothes. Secured fixation may be desirable for example during sports activities or for children. PARENTAL GUIDANCE �� Especially for children it is recommended to use the attachment clip in situations with a risk of the device falling off. -
Page 18: Cleaning
If you live in a humid climate or perspire heavily, it is recommended to use a drying kit for storage (sold separately). The audio processor must not be disposed of with household waste. You are responsible for disposing the audio processor by returning it to MED-EL or your local MED-EL represen- tative. Compatibility with optional user accessories •... -
Page 19: Troubleshooting
Troubleshooting 5. Troubleshooting Problem Possible cause Recommended action No sound No battery inserted Insert a new battery (see section Changing the battery). Battery empty Foil covering the battery still Remove the foil covering the battery (see section in place Changing the battery). Battery inserted upside Check for correct battery position (check polarity, flat down... - Page 20 Troubleshooting Problem Possible cause Recommended action Sound too loud Volume is turned too high 1. Open and close the battery compartment to reset the audio processor to the default program and volume. 2. The optional SAMBA 2 Remote app or the SAMBA 2 GO streaming device could be used to adjust predefined volume or program settings.
- Page 21 Troubleshooting Problem Possible cause Recommended action Another remote Interference Contact your audiologist/healthcare professional. control affects your audio processor Unusual sounds, Signal interference with 1. Move away from any possible source of interference. unexpected audible other equipment (e.g. In case you are in an area where theft and metal sensations with hand-held computers, detection systems are used (e.g.
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Page 22: Audiologist/Healthcare Professional Information
If your client refuses to wear the audio processor or indicates uncomfortable hearing sensations, immediately remove and turn off the audio processor and check the system. Do not hesitate to contact your MED-EL representative for any information not provided in these instructions for use. -
Page 23: Information And Recommended Training
IEC 60601-1 electrical safety standard. If there are any questions, please consult with MED-EL or the regional represen- tative. Also refer to section General information of these instructions for use and the hearing aid... -
Page 24: Programming The Samba 2
CAUTION ⚠ Only use the Battery Pill 675 and the Programming Cable CS64 provided by MED-EL for wired programming. Using other battery pills and programming cables may result in increased electro- magnetic emissions or decreased immunity of the audio processor. -
Page 25: Changing The Magnet
Audiologist/healthcare professional information Changing the magnet The number of dots on the magnet, from one to six, indicates the magnet strength. The magnet strength chosen should be appropriate for the individual user, e.g. weak magnets are indicated for users with thin skin flaps (e.g. children), to reduce the likelihood of skin irritation. -
Page 26: Advanced Troubleshooting For The Audiologist/Healthcare Professional
2. Change the cover (see section Changing the cover) and perform a sound check. 3. Contact your MED-EL representative if the problem persists. Sound too loud Fitting program needs Stop client from using the audio processor. - Page 27 Contact your MED-EL representative for specific information not available in some or information about other options. countries Audio processor is Various causes Contact your MED-EL representative if you cannot solve the damaged problem. A problem persists after trying the recommended...
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Page 28: Warnings And Precautions
30 cm (12 in) to any part of the audio processor, including cables specified by MED-EL. Otherwise, degradation of the performance of the audio processor could result. -
Page 29: Precautions
Warnings and precautions Precautions General The audio processor contains complex electronic parts. These parts are durable but must be treated with care. The audio processor must never be disassembled by anyone other than authorized service personnel. The magnet compartment must be opened only by a trained audiologist/healthcare professional. -
Page 30: Possible Adverse Events Associated With Bonebridge Surgery
Warnings and precautions If the audio processor gets wet, turn it off, remove the battery and gently wipe the outside dry, using a soft absorbent cloth. Then allow the audio processor to dry out (preferably overnight). If in doubt, repeat the drying process. If the humidity problem persists, return the audio processor to your audiologist/healthcare professional for repair or replacement. -
Page 31: Interference With Other Equipment
• Magnetic resonance imaging (MRI) safety information: The external components of the MED-EL implant system (audio processor and accessories) are MR Unsafe and need to be removed prior to scanning. Bone Conduction Implant (BCI 601 or BCI 602) •... - Page 32 • Magnetic resonance imaging (MRI) safety information: The external components of the MED-EL implant system (audio processor and accessories) are MR Unsafe and need to be removed prior to scanning. The implant components of the MED-EL implant system are MR Conditional.
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Page 33: Initial Activation
Warnings and precautions The audio processor shall not be worn during an MRI examination; however, it is still possible that audible interference can occur. Adequate counseling of the patient is advised prior to performing the MRI. The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower SAR and slower gradient slew rates. -
Page 34: Clinical Summary
MED-EL Bonebridge system in conductive and mixed hearing losses (CHL, MHL). Six tests were evaluated in order to determine safety and effectiveness of the MED-EL Bonebridge system pre-operatively and one and three months post-operatively: Word recognition score (WRS;... - Page 35 Clinical summary Primary study endpoint The primary effectiveness endpoint was the improvement in speech perception in the post-activation aided condition compared to the pre-operatively unaided condition. A change of at least 15 % in the word recognition scores (Freiburger monosyllables) was considered clinically significant.
- Page 36 Clinical summary Inclusion criteria Subjects were eligible for enrollment in the study if they fulfilled the following criteria: General inclusion criteria: a. Geographically and physically able to return to the investigational center for scheduled evaluations and follow-up appointments b. Fluency in the language used in the investigational center and used for evaluation No prior or current use of an active middle ear hearing implant or bone anchored hearing aid in either ear d.
- Page 37 Clinical summary Exclusion criteria Subjects were excluded from the study for any of the following reasons: a. Chronic or non-revisable vestibular or balance disorders b. Abnormally progressive hearing loss Chronic pain in or about the head d. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment The following exclusion criteria apply for all subjects: e.
- Page 38 Clinical summary Audiometric tests (basic test battery) The following tests were conducted on each ear individually: Bone conduction (BC) BC was tested by pure tones applied via a bone conduction vibrator at the mastoid and thresholds were measured using a standard bracketing procedure at 0.5, 1, 2, 3 and 4 kHz. Air conduction (AC) AC was tested by pure tones applied using insert earphones or traditional headphones and thresholds were measured using a standard bracketing procedure at 0.5, 1, 2, 3, 4, 6 and...
- Page 39 Clinical summary Clinical trial results The table below provides details on the number of subjects for each interval completed. # of subjects Total Pre-operative 12 adult and 12 pediatric 1 month post-operative (initial activation) 12 adult and 12 pediatric 3 months post-operative 12 adult and 12 pediatric Demographics The table below provides information on subject demographics, including gender, age at...
- Page 40 Clinical summary Speech perception result (primary endpoint effectiveness) For the primary endpoint of improvement on Freiburger monosyllabic words in quiet the average unaided pre-operative word recognition score correct was 14.55 % (±21.62 %) for pediatric and 14.17 % (±18.07 %) for adult subjects. Three months post-operative, in the Bonebridge-aided condition, subjects’...
- Page 41 Clinical summary Speech perception result (secondary endpoint effectiveness) Additionally, improvement in speech understanding in quiet was assessed with OLSA speech reception threshold sentences in quiet. Pediatric subjects improved from mean 72.70 dB SPL (±5.94 dB SPL) pre-operatively unaided to mean 45.18 dB SPL (±6.95 dB SPL) three months post-operatively aided with the Bonebridge.
- Page 42 Clinical summary Audiometric results sound field (secondary endpoint effectiveness) Pediatric subjects improved from mean 55.95 dB SPL (±3.04 dB SPL) pre-operatively unaided to mean 28.99 dB SPL (±3.97 dB SPL) three months post-operatively aided with the Bonebridge. Adult subjects improved from mean 57.98 dB SPL (±3.07 dB SPL) pre-oper- atively unaided to mean 33.33 dB SPL (±3.97 dB SPL) three months post-operatively aided with the Bonebridge.
- Page 43 Clinical summary Audiometric results basic test battery (secondary endpoint safety) The secondary endpoint of unchanged residual hearing was measured by unaided audiologic thresholds from pre-operatively unaided to the three-month post-operative endpoint. The results of descriptive analyses of BC and AC thresholds presented below show that Bonebridge treatment had no effect on residual hearing.
- Page 44 Clinical summary Air conduction thresholds PRE‑OP pediatrics dB HL Std. dB HL Std. dB HL Std. 0.5 kHz 64.58 16.71 65.45 16.50 65.00 17.71 1 kHz 56.25 17.21 57.27 16.79 61.25 12.99 2 kHz 56.25 17.73 54.09 15.14 56.67 12.67 3 kHz 57.08 22.20...
- Page 45 Clinical summary Subjective device satisfaction (secondary endpoints) On average, pediatric and adult subjects were satisfied to very satisfied three months after the Bonebridge treatment. Only one adult subject was sometimes satisfied/dissatisfied with the device at the three-month evaluation time point. Figure 5: HDSS mean overall satisfaction three months post-operatively for pediatric and adult subjects.
- Page 46 Clinical summary Safety Adverse events were collected for all implanted subjects throughout the duration of the study. Adverse events were classified as non-serious/serious, device/procedure-related or unrelated. A total of 5 adverse events occurring in 5 subjects were reported as related to either the device or the procedure. No serious adverse event related to the procedure or the device was reported during the course of the BB001 study.
- Page 47 MED-EL Bonebridge system in conductive and mixed hearing losses (CHL, MHL). Six tests were evaluated in order to determine safety and effectiveness of the MED-EL Bonebridge system pre-operatively and one, three and twelve months post-operatively: Word recognition score (WRS;...
- Page 48 Clinical summary Safety was further evaluated by tabulations of all adverse events (AEs) and serious adverse events (SAEs). Safety data was collected on all implanted subjects. The third secondary endpoint was the subjective hearing device benefit and device satisfaction measured using the HDSS questionnaire. Inclusion criteria Subjects were eligible for enrollment in the study if they fulfilled the following criteria: General inclusion criteria:...
- Page 49 Clinical summary Exclusion criteria Subjects were excluded from the study for any of the following reasons: a. Chronic or non-revisable vestibular or balance disorders b. Abnormally progressive hearing loss Evidence that hearing loss is of retrocochlear or central origin d. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment e.
- Page 50 Clinical summary Audiometric tests (sound field) The following test was conducted in a sound field with the speaker at 0° azimuth and 1 m away from and at level with the subject’s head in a sound-attenuated room. Warble tones (WT) WT were applied in the sound field and thresholds were measured using a standard bracketing procedure at 0.5, 1, 2, 3, 4, 6 and 8 kHz.
- Page 51 Clinical summary Clinical trial results Of the 57 total subjects implanted, 53 had reached the twelve-month post-operative time point on the date of analysis. One subject withdrew from the study after implan- tation; therefore, safety results for 52 subjects and audiometric results for 52 subjects were analyzed.
- Page 52 Clinical summary Parameter/category or statistic Total (N = 53) Adult (N = 45) Pediatric (N =8 ) Disease etiology Chronic otitis media 30.19 28.30 1.89 Atresia 22.64 16.98 5.66 Cholesteatoma 20.75 20.75 Ear dysplasia 7.55 5.66 1.89 Malformation 1.89 1.89 Ear dysplasia/Franceschetti syndrome 1.89 1.89...
- Page 53 Clinical summary Speech perception result (primary endpoint effectiveness) For the primary endpoint of improvement on Freiburger monosyllabic words in quiet, the average unaided pre-operative score was 19.57 % (±21.7 %) correct. Twelve months post-operatively, in the Bonebridge-aided condition, subjects’ mean score was 82.9 % (±18.1 %) correct.
- Page 54 Clinical summary Speech perception result (secondary endpoint effectiveness) Additionally, improvement in speech understanding in quiet was assessed with OLSA speech reception threshold sentences in quiet. Subjects improved from mean 63.69 dB SPL (±11.81 dB SPL) pre-operatively unaided to mean 39.71 dB SPL (±8.84 dB SPL) twelve months post-operatively aided with the Bonebridge.
- Page 55 Clinical summary Audiometric results sound field (secondary endpoint effectiveness) For the secondary endpoint of improvement on warble tones, the average unaided pre-op- erative threshold improved from 56.94 dB SPL (±12.57 dB SPL) to 29.33 dB SPL (±8.83 dB SPL) twelve months post-operatively in the aided condition. The mean functional gain was 28.89 dB SPL in the Bonebridge-aided condition twelve months post-operatively.
- Page 56 Clinical summary Audiometric results basic test battery (secondary endpoint safety) The secondary endpoint of unchanged residual hearing was measured by unaided audiologic PTA4 (0.5, 1, 2 and 4 kHz) thresholds from pre-operatively unaided to the twelve-month post-operative endpoint. The results of descriptive analyses of BC and AC thresholds presented below show that Bonebridge treatment had no effect on residual hearing.
- Page 57 Clinical summary Subjective device satisfaction (secondary endpoints) On average, subjects were satisfied or very satisfied three months after the Bonebridge treatment (80.8 %) and this result remained stable at the twelve-month (80.2 %) post-op- erative appointment. Only two adult subjects were just under 50 % satisfied at the three months evaluation time point (48.68 % and 48.75 %, respectively) with both being more satisfied at the twelve months appointment (50 % and 67.11 %).
- Page 58 Clinical summary Safety Adverse events were collected for all implanted subjects throughout the duration of the study. Adverse events were classified as non-serious/serious, device-/procedure-related or unrelated. A total of 31 adverse events, one temporary loss of residual hearing and one serious adverse event unrelated to the procedure or the device were reported up to twelve months after implantation.
- Page 59 (SSD) on the long-term scale up to at least thirteen months after surgery. Three tests were evaluated in order to determine benefit of the MED-EL Bonebridge sys- tem at baseline (at initial fitting one-month post-operatively) and six and twelve months...
- Page 60 Clinical summary Inclusion criteria a. Bonebridge users aged 18 years or older b. Single-sided sensorineural deafness, that is severe-to-profound sensorineural deafness in one ear while the other ear has normal hearing (air conduction should be equal to or better than 20 dB HL measured at 0.5, 1, 2 and 3 kHz) Frequency (kHz) AC upper limit (dB HL) Table 3: Indication range upper limits (dB HL) of air conduction thresholds as a function of frequency for the...
- Page 61 Clinical summary –5 to +5, where –5 indicates ‘much worse’ with the Bonebridge than without, while +5 indicates ‘much better’. The midpoint of the scale (0) indicates that the ability or experience is ‘unchanged’. A positive rating always indicates an improvement with the Bonebridge, while a negative rating always indicates worse ability or experience.
- Page 62 Clinical summary Speech perception results (primary endpoint) Statistical analysis revealed a significant improvement between the aided and the unaided test condition at baseline testing (p = 0.002), and at long-term twelve-month testing (p = 0.007). A trend to significance was reached at six-month testing (p = 0.021), which would be significant without correction for multiplicity by Bonferroni correction with p <0.05.
- Page 63 Clinical summary Subjective device satisfaction (secondary endpoints) SSQ‑B Overall the outcome of the SSQ-B shows that subjects with SSD benefited from the Bonebridge treatment as an overall mean improvement was reached for all subscales. For the SSQ-B, only one subject (9.99 %) reported a worse experience with the Bonebridge at twelve months.
- Page 64 Clinical summary BBSS Overall the outcome of the BBSS shows that subjects with SSD benefited from the Bonebridge treatment as an overall mean improvement in summed scores was reached. All subjects reported benefit with Bonebridge according to the BBSS. Figure 13: BBSS overall total score; six and twelve months after baseline for all subjects.
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Page 65: Miscellaneous
Miscellaneous 9. Miscellaneous Technical data Dimensions Primarily circular shape Length: 36.4 mm (1 7/16 in) (battery compartment closed) Width: 30.4 mm (1 3/16 in) Height: 10.2 mm (13/32 in) (tallest point) Weight including battery and magnet (strength 1): 9.3 g (0.33 oz) Material in tissue contact Eastman Tritan Copolyester MX731 Power supply... - Page 66 Miscellaneous EMC compliance information Emissions test RF emissions Group 1, Class B CISPR 11 Immunity Electrostatic discharge (ESD) +/–8 kV contact, +/–15 kV air IEC 61000-4-2 Radiated RF 80 MHz to 6 GHz 10 V/m IEC 61000-4-3 380 MHz to 390 MHz 27 V/m 430 MHz to 470 MHz 28 V/m...
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Page 67: Warranty Statement
Miscellaneous Warranty statement Please refer to the accompanying Warranty Statement for information on our warranty provisions. Symbols CE marking, first applied in 2020 Caution Refer to instructions for use Manufacturer Serial number Catalog number Fragile, handle with care Temperature limit Humidity limitation Type BF applied part (IEC 60601-1/EN 60601-1): The bottom surface of the SAMBA 2, which is in contact with the patient, is a Type BF applied part. -
Page 68: Radio Frequency/Telecommunication Information
Miscellaneous Information indicating a hazardous situation that, if not avoided, could result in death or serious injury. Information particularly relevant for parents, guardians or caregivers of children who use the system. Radio frequency/Telecommunication information Radio equipment registration number: FCC ID: VNP-WL607 NOTICE: This device complies with Part 15 of the FCC Rules. - Page 69 Miscellaneous Please help us to improve the quality of these instructions for use by making any sugges- tions. For further information regarding the use of this MED-EL product, or to report any problems, please contact: MED-EL Elektromedizinische Geräte GmbH Fürstenweg 77a...
- Page 72 2.5x MED-EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria offi ce@medel.com medel.com 2.5x...
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