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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

Summary of Contents for SAMBA 2

Page 1: ...Business Unit Vibrant AW53003_1 0 English US SAMBA 2 Audio Processor English...

Page 2: ......

Page 3: ...volume 10 SAMBA 2 Remote app 10 Battery status 11 Changing the battery 11 Changing the cover 14 Using the attachment clips 15 Maintenance 15 Cleaning 16 Storage handling and disposal 16 Compatibility...

Page 4: ...ossible 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...

Page 5: ...Contents of the package 3 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: ...ll be used throughout this document Information indicating a hazardous situation that if not avoided could result in death or serious injury Information indicating a hazardous situation that if not av...

Page 7: ...sion processor The device is powered by a single 675 zinc air battery The Bonebridge system is activated by simply fitting the audio processor The audio processor is intended for the home use environm...

Page 8: ...verview Microphone openings Indicator relevant for users with two implants right side left side Magnet Interchangeable cover Battery compartment Air vents Bracket groove recess for attachment clip fix...

Page 9: ...2 is a component of the Bonebridge system all indications and contraindi cations for the Bonebridge are applicable NOTE Important information related to indications contraindications warnings and risk...

Page 10: ...ff Always open the battery compartment whenever the audio processor is not in use to extend the life of your device s battery PARENTAL GUIDANCE If the child user refuses to wear the audio processor or...

Page 11: ...SAMBA 2 Audio Processor before placing the devices over the implants right side application left side application CAUTION Take care not to drop the audio processor during handling Keep good hold of th...

Page 12: ...e without the need for any additional hardware The app is free to download from the Google Play Store or Apple App Store The SAMBA 2 Remote app generates short control signals which may be audible Whi...

Page 13: ...nergy efficient and has a battery lifetime of approximately 8 to 10 days This is based on an average daily use of 12 6 to 16 hours at an average volume level The battery life of the audio processor ma...

Page 14: ...y follow these steps Remove used battery Insert new battery 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 z...

Page 15: ...batteries according to local regulations PARENTAL GUIDANCE Parents guardians or caregivers are advised to regularly change the battery as necessary and if in doubt check the status of the battery WAR...

Page 16: ...applied correctly the cover snaps into place easily Do not apply undue force NOTE The battery does not have to be removed to change the cover Close the battery compartment Insert your fingertips into...

Page 17: ...ment and hold the battery compartment closed before you remove the attachment clip from the audio processor Maintenance Your audio processor is designed for durability and reliability When handled wit...

Page 18: ...cessor 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 res...

Page 19: ...zinc air battery has been sufficiently subjected to air 2 Check the battery compartment if the air vents are clogged and remove dirt obstructions 3 If you cannot solve the problem yourself contact yo...

Page 20: ...processor falls off frequently Hair over implant too thick Thin out your hair over the implant or in rare cases shave your hair directly under the audio processor to about 6mm in Magnet too weak Conta...

Page 21: ...tection systems 1 Move away from any possible source of interference In case you are in an area where theft and metal detection systems are used e g security check points temporarily remove the audio...

Page 22: ...presentative for any information not provided in these instructions for use Supplementary equipment to program and handle the SAMBA 2 The equipment shall consist of SYMFIT 8 0 or higher programming so...

Page 23: ...fitting by the audi ologist healthcare professional the programming cable and the battery pill both available separately must be compliant with Type BF of the electrical safety standard IEC 60601 1 E...

Page 24: ...sert the battery pill into the battery compartment as shown in the figure below Close the battery compartment Do not force the battery compartment to close check for the correct position of the batter...

Page 25: ...g weak magnets are indicated for users with thin skin flaps e g children to reduce the likelihood of skin irritation To change the magnet follow these steps Turn device upside down Place magnet excha...

Page 26: ...ed Check the program characteristics via SYMFIT 8 0 or higher Electrical problems Contact your MED EL representative Insertion of battery pill not possible Battery pill not inserted correctly Position...

Page 27: ...r than Android and iOS The system requirements of the SAMBA 2 Remote app can be found in the app store SAMBA 2 Remote app not available in some countries Contact your MED EL representative for specifi...

Page 28: ...equipment including peripherals such as antenna cables and external antennas should be used no closer than 30cm 12in to any part of the audio processor including cables specified by MED EL Otherwise d...

Page 29: ...audiologist healthcare professional Head trauma A blow to the head may damage the implant and result in its failure Implant recipients are strongly encouraged to use head protection whenever possible...

Page 30: ...ed from an implant and the cause or degree of hearing impairment has not yet been evaluated There are no definitive tests that can be administered prior to implantation to estimate the degree of benef...

Page 31: ...lant should be advised that passing through security metal detectors may activate the detector alarm For this reason it is advised that users carry their User Identification Card at all times RFID Cer...

Page 32: ...ion 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...

Page 33: ...wer SAR and slower gradient slew rates The above instructions should also be followed if areas of the body other than the head are to be examined e g knee When lower extremities are to be examined it...

Page 34: ...f 13 adults to demonstrate the clinical benefit of the Bonebridge in single sided deafness SSD on the long term scale up to at least 13 months after surgery Prospective clinical study Bonebridge in CH...

Page 35: ...one or more test frequencies was considered significant The secondary safety endpoints were stable hearing thresholds for bone conduction char acterized by no difference between pre and post operative...

Page 36: ...limitations of the Bonebridge i The physician must fully assess the potential risks and benefits for the patient prior to the decision to implant the Bonebridge The physician must exercise medical ju...

Page 37: ...able to undergo general or local anesthesia Description of tests Speech perception testing The following tests were conducted in a sound field with the speaker at 0 azimuth and 1m away from and at lev...

Page 38: ...ocedure at 0 5 1 2 3 4 6 and 8kHz Device satisfaction benefit Hearing device satisfaction scale Subjective device satisfaction was tested by means of the hearing device satisfaction scale HDSS hearing...

Page 39: ...er Male 29 17 N 7 25 N 3 33 3 N 4 Female 70 83 N 17 75 N 9 66 7 N 8 Age years mean min max 28 5 69 44 19 69 11 5 17 Implant side Left 29 2 N 7 25 N 3 33 3 N 4 Right 70 8 N 17 75 N 9 66 7 N 8 Previous...

Page 40: ...ric subjects showed an improvement in word recognition score Figure 1 Word recognition scores for pediatrics and adults Box plots median horizontal lines mean ANOVA alpha level 0 05 significance red c...

Page 41: ...an horizontal lines mean red circles depict distribution of individual values Pre op pre operative 1M one month post operative 3M three months post operative OLSA Pediatric N 12 Adult N 12 Speech Rece...

Page 42: ...1 M 3 M pediatrics dB HL Std N dB HL Std N dB HL Std N MEAN 55 95 3 07 12 32 44 4 04 12 28 99 3 97 12 0 5kHz 60 00 16 38 12 40 00 14 30 12 37 50 10 98 12 1kHz 53 33 11 15 12 30 00 10 45 12 27 50 8 66...

Page 43: ...diatric and adult subjects The rectangular area light grey depicts the indication range of 45dB HL pre operatively Bone conduction thresholds PRE OP 1 M 3 M pediatrics dB HL Std N dB HL Std N dB HL St...

Page 44: ...2 50 42 17 77 12 3kHz 55 83 15 50 12 56 25 15 09 12 52 08 21 37 12 4kHz 58 75 14 79 12 59 58 9 64 12 54 58 19 48 12 6kHz 66 82 16 32 11 68 33 18 26 12 66 67 27 33 12 8kHz 65 00 21 21 9 60 00 14 36 9 5...

Page 45: ...t Figure 5 HDSS mean overall satisfaction three months post operatively for pediatric and adult subjects Box plots median horizontal lines mean 100 very satisfied 75 satisfied 50 sometimes satisfied d...

Page 46: ...verse event related to the procedure or the device was reported during the course of the BB001 study Details on the type and number of device and procedure related adverse events can be found in the t...

Page 47: ...he 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 significa...

Page 48: ...alistic expectations of the benefits and limitations of the Bonebridge f Emotional and psychological ability to understand and perform on required study procedures g The patient should have tried any...

Page 49: ...profound sensorineural deafness in one ear while the other ear has normal hearing k Pathological conditions causative for inner ear hearing instability threshold fluctua tion or progressive inner ear...

Page 50: ...4kHz Air conduction AC AC was tested by pure tones using insert earphones or traditional headphones and thresholds were measured using a standard bracketing procedure at 0 5 1 2 3 4 6 and 8kHz Device...

Page 51: ...2 months post operative 50 Demographics The table below provides information on subject demographics including gender age at implantation average of previous ear surgeries and number of subjects with...

Page 52: ...atoma 20 75 11 20 75 11 Ear dysplasia 7 55 4 5 66 3 1 89 1 Malformation 1 89 1 1 89 1 Ear dysplasia Franceschetti syndrome 1 89 1 1 89 1 Chronic mastoiditis 1 89 1 1 89 1 Stenosis 1 89 1 1 89 1 Anomal...

Page 53: ...nths which recovered at a later appointment to 95 Figure 6 Word recognition scores for all subjects Box plots median horizontal lines mean ANOVA alpha level 0 05 significance red circles depict distri...

Page 54: ...subjects Box plots median horizontal lines mean red circles depict distribution of individual values Pre op pre operative 1M one month post operative 3M three months post operative 12M twelve months...

Page 55: ...2 and 4kHz Box plots median horizontal lines mean red circles depict distribution of individual values Pre op pre operative 1M one month post operative 3M three months post operative 12M twelve month...

Page 56: ...post operative 17 17 10 39 52 18 59 10 27 44 9 38 7 53 8 3 months post operative 15 66 8 63 52 16 88 8 63 44 8 91 4 88 8 12 months post operative 17 03 10 24 50 18 11 10 25 43 10 36 7 83 7 AC Total N...

Page 57: ...twelve month appointment 97 44 were satisfied with the device and just one subject or 2 56 were sometimes satisfied dissatis fied with the device Figure 10 HDSS mean overall satisfaction three and twe...

Page 58: ...rocedure related adverse events One subject who experienced a SADE on skin infection and subsequent explanta tion was excluded from the study analysis as the inclusion criteria were not met from the b...

Page 59: ...ad attended the twelve month after baseline testing appointment at the time point of analysis in August 2016 Primary study endpoint It is expected that speech understanding in noise will improve in in...

Page 60: ...y able to understand and perform on required study procedures Exclusion criteria h Lack of compliance with any inclusion criteria i Lack of compliance in regularly using the device 4 to 6 hours per da...

Page 61: ...rating always indicates worse perceived benefit The BBSS originally assesses the subjective benefit of unilaterally deaf patients when using a CROS device contralateral routing of signals The question...

Page 62: ...baseline 2 26dB SNR at six months and 1 62dB SNR at twelve months At twelve months 88 89 of all subjects showed improved SNRs Figure 11 SNR S90 N0 unaided compared to the aided condition at baseline...

Page 63: ...articipants 90 91 reported a better experience Figure 12 SSQ B speech spatial qualities overall total score six and twelve months after baseline for all sub jects Box plots median horizontal lines mea...

Page 64: ...months post operative 25 69 7 99 10 12 months post operative 19 61 8 30 9 BBSS in of subjects BETTER EQUAL or WORSE Pre operative vs BETTER EQUAL WORSE 6 months post operative 100 0 00 0 00 12 months...

Page 65: ...Operating conditions Temperature 5 C 41 F to 40 C 104 F Relative humidity 15 to 90 Atmospheric pressure 70 to 106kPa Conditions of transport and storage between uses Temperature 25 C 13 F to 60 C 140...

Page 66: ...7 5A m Conducted RF on programming cable only IEC 61000 4 6 0 15 MHz to 80 MHz 3 Vrms ISM amateur bands 10 Vrms Power frequency 50 60Hz magnetic field IEC 61000 4 8 30A m Audio quality may be comprom...

Page 67: ...midity 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 Non ionizing electromagnetic radiation Du...

Page 68: ...adio equipment registration number FCC ID VNP WL607 NOTICE This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful i...

Page 69: ...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 Ge...

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Page 72: ...MED EL Elektromedizinische Ger te GmbH F rstenweg 77a 6020 Innsbruck Austria office medel com medel com...

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