implantable course 2015 med el

Active Middle Ear ImplantMED-EL Soundbridge

Darius Kohan, M.D.Director of Otology/Neurotology

Lenox Hill HospitalManhattan Eye, Ear, and Throat Hospital

New York CityNew York, NY

March 20, 2015

Disclosures

• Financial – None• Some Slides Courtesy of MED-EL

MED-EL Soundbridge

Amplification vs. Direct Drive• Amplification issues:

o Occlusion, insertion loss, feedback

• Direct drive solutions:o Mechanical energy delivered

directly to the ossicleso Enhances natural vibratory motiono Eliminates many of the acoustic issues

inherent in amplification

Approved Indications – United States• Adults, 18 yrs. or older• Bilateral moderate to severe

sensorineural hearing loss• Normal middle ear anatomy and

function• Speech understanding >50% at

65 dB for word lists (recorded) in best aided condition

• Dissatisfied with or unable to tolerate hearing aids

• Realistic expectationsThese patients are not successful or satisfied hearing aid users!

• Sound quality in noise• Over amplification of background noise• Distortion• Difficulty to hear speech clearly

• Sound quality of own voice• Occlusion effect• Over-amplification of their voice• Distortion

• Feedback• Reduction in sound quality• Annoying and embarrassing

Main Reasons for Dissatisfaction with Hearing Aids

Unable to Use Hearing Aids: Main Medical Issues• Chronic otitis externa• Exostosis (external ear bone growth closing the ear canal)• Eczema of the ear• Psoriasis

• Furonculosis (acute localized otitis externa)

• Allergies

• Absence of pinna

• Mandibular fractures of the jaw

• Collapsed or stenosis of ear canal

• Excessive wax production• Excessive perspiration

Who is Not a VSB Candidate

• Conductive hearing loss

• Progressive or sudden hearing loss

• Active middle ear infections

• Tympanic membrane perforations w/ recurrent middle ear infections

• Retrocochlear or central auditory disorder

• A skin or scalp condition precluding attachment of Audio Processor™

• Unrealistic expectations!

Vibrating Ossicular Prosthesis (VORP)

FMT - Floating Mass Transducer

2.3 mm x 1.8 mm25 mgs

Floating Mass Transducer (FMT)

• Electromagnetic transducer

• Generates the vibratory motion

• Reproduces and augments the natural movement of the ossicular chain

Single Point Attachment

• Vibrant Soundbridge is a middle ear implant with single point

attachment

• FMT only attached to one single middle ear structure without

skull attachment

• Independent of skull growth

The VORP Template is used by the surgeon to identify the correct position of the VORP during the implantation process.

VORP Template

The flap is examined during surgery, the flap should fit easily into the gauge.

If the flap is too thick, it should be thinned to ensure a good magnetic fixation of the AP.

The skin flap gauge 7 is used to ensure that the skin flap is 7mm or less prior to surgical closure.

Skin Flap Gauge 7

45

Plan Device Placement

Postauricular Incision

Endaural Incision

Create Facial Flap

Confirm Incision Size

Confirm Skin Flap Thickness

Standard Mastoidectomy

Confirm VORP Transition Placement

Drill Seat for Demodulator

Confirm Position Using Template

Create Tie-Down Holes

Posterior Tympanotomy

• Caution: ossicular chain should not be drilled

• Large enough to allow clear visualization of the long process of the incus



Suture Demodulator In Place

Suture Demodulator In Place

Position FMT

Arrange Conductor Link

Verify FMT Position

The FMT is parallel to the stapes

AD

Position of FMT on Incus

AS

Surgical viewthrough facial recess

“Rear” viewtowards facial recess

FMT Attachment Configuration

Essential:• FMT perfectly attached to the long process of the incus• FMT in contact with low part of the stapedial arch• FMT should not be in contact with other bony parts, like

the promontory

PLACING the FMT

Placing the FMT

Suture Flap Over Demodulator

Amadé Details

• 16 band digital audio processor

• 8 compression channels

• Directional microphone (optional)

• Frequency band: 250-8kHz

• Max output= 110 dB

• Specific R and L processors

Wide Frequency Range

Audio processor supports frequencies up to 8000 Hertz• Delivers in high amplifications

• Up to 40dB more gain at high frequencies than conventional hearing aids

Program Settings• Patient can switch between three individual programs.

• Audiologist can choose from six different templates

• Television • Music • Outdoor• Sports• Noisy environment

• Each template adjustable individually

• Provides best hearing sensation

VORP Reliability (Cumulative Survival Rate)

After a period of over 7 years, 99.29% of all implants are still functioning

10

0,0

0%

99

,92%

99

,83%

99

,74%

99

,74%

99

,62%

99

,62%

99

,62%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

99

,29%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

3 6 9

12

15

18

21

24

27

30

33

36

39

42

45

48

51

54

57

Time Intervals [months]

Cu

mu

lati

ve

Su

rviv

al

CSR - device related / Total / Entire Population as per: 23.01.2009

Cumulative Experience: 2920 Implant Years

Reliability remained stable from 27-57 months

Long-Term Follow-Up: Effect on Hearing

• 77 of 100 implanted patients

• 5- to 8-year use of VSB

• Functional gain remained statistically unchanged

• No effect on hearing thresholds when compared to contralateral ear

Mosnier et al. Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years. Ear Hear. 2008;29(2):281-284.

*statistically significant

Subjective Results• Luetje et al., 2002, n = 94

• PHAB: Profile of Hearing Aid Performance Hearing Aid vs. Vibrant Soundbridge

Sit

uat

ion

s W

ith

ou

t P

rob

lem

s (

%)

010

20304050

607080

90100

Familiar Talkers Ease ofCommunication

Reverberation Reduced Cues BackgroundNoise

Aversiveness ofSounds

Distortion ofSound

Global

PHAP Subscales

Hearing Aid Vibrant Soundbridge* 12 Months

* ** * *

* * *

Speech Perception in QuietTruy et. Al. (2008)

____ unaided

__ __ __

VSB

- - - - - Hearing aid

Largest difference between VSB and hearing aid noted

the lower the intensity level of

stimulus

Speech Perception in NoiseTruy et.al (2008)

____ unaided__ __ __VSB- - - - - Hearing aid

VSB out-performed the HA for all S/N

Long-Term Clinical Results Mosnier et al., 2008, Ear & Hearing

After 5-8 years of VSB use:

• Functional gain remained unchanged

• Good, stable speech comprehension over time

• 77% were satisfied or very satisfied after 5-8 years (vs. 80% @ 18 mo post-op)

ComplicationsU.S. Patients (n=81)

Description Reported Unresolved

Device Failure 6 0

Transient Facial Pareses 2 0

Infection 1 0

Episodic Dizziness 2 0

Change in Residual Hearing 2 2

Fullness Sensation 18 13

Perforated Tympanic Membrane 1 0

Altered Taste Sensation 7 2

Skin Irritation 2 0

Transient Pain 13 4

Disconnection of FMT 1 0

Round Window VibroplastyBypass Amplification

CAUTION: Investigational device. Round Window Vibroplasty w/ Vibrant Soundbridge is limited by Federal law to investigational use.

Round Window VibroplastyColletti et al. (2006)

• Drilling of bone close to the RW to allow placement of FMT in round window

• RW vibroplasty used at surgeon’s discretion when the ossicles are not appropriate for classical placement of FMT (e.g. missing, malformations etc.)

A

B

RW MembraneMucosal Folds (“false membrane”)

CAUTION: Investigational device. Limited by Federal law to investigational use.

Hook region of the RW (A)Hypotympanum (B)

The FMT sits perpendicular to the RW membrane and is encapsulated in fascia.

Final Position of the FMT


Known Complications

Round Window Vibroplasty• Same risks as incus placement• Patients with multiple middle ear surgeries may

have an increase risk foro FMT migrationoConductor link extrusion


FMT and Pistons• Stapes replacement used

together with FMTo either FMT over pistono Or piston over FMT

MED-EL recommends a two-stage surgery:

1. Stapedectomy

2. VSB placement to resolve remaining SN loss


*Vibrant Soundbridge is undergoing investigation in the US for conductive and mixed hearing loss

**Bonebridge is not approved for use in the USA***Single-Sided Deafness is a CE marked indication but not an

approved indication in the USA

General Indication Focus

Bonebridge

**Bonebridge is not approved for use in the USA

Bonebridge

An active Bone Conduction Implant

Transcutaneous technology proven in CIs and MEIs now available for bone conduction stimulation


The BCI Implant

TRANSDUCER „BC-FMT“

ELECTRONICS PACKAGE

COIL AND ATTACHMENT MAGNET

FLEXIBLE TRANSITION


Bonebridge Product Features

• Implant and transducer safely embedded under intact skin

• Direct drive bone conduction • Highly efficient transducer

(BC-FMT)• Force-free implant magnet:

MRI conditional up to 1.5T• No maintenance of the implant• State of the art signal processing• Battery life 5-7 days


How the Bonebridge Differs from Other Bone-Anchored Hearing Devices

• Transcutaneous rather than percutaneous – No abutment– Preliminary evidence suggests infection rate very low (similar to CI)

• Vibrating structure is implanted not part of external device– No problems with flap degeneration due to vibration

• Complete osseointegration not required– Vibration occurring through titanium screws holding internal device in place– No force being placed on screws with removal of device because it is

transcutaneous

European Clinical Trial Results

• Sprinzl et. Al (2013) First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol 1-8.

Clinical Trial

Mean audiometric bone conduction thresholds for the implanted ear: pre-operative testing compared to 3 month post-op testing. Error bars reflect ± standard deviation. (n=12)

The Bonebridge Clinical Investigation

Mean / median percent correct word recognition scores in quiet (Freiburger monosyllables) for the implanted ear: pre-operative testing compared to 3-month testing. Mean values are depicted as black squares, median values are depicted as horizontal line. (n=12)

pre-operative 1 month post-operative 3 month post-operative0

10

20

30

40

50

60

70

80

90

100

mean 14.2

0

mean 82.9

0

mean 92.9

Word Recognition Score

Mea

n /

Med

ian

perc

ent c

orre

ct


Mean / median SRT50% in Quiet (OLSA sentences) for the implanted ear: pre-operative testing compared to 3-month testing. Mean values are depicted as black square, median values are depicted as horizontal line. (n=12)


Clinical Trial: Subjective Device Satisfaction


Mean device satisfaction was 79%

Sound quality in different situations

Handling of the device Speech comprehension in

noise Cosmetics Improvement of life quality

And more…

Results of the Hearing Device Satisfaction Scale (HDSS): Individual overall satisfaction with the device as percentage values 3 month post-op

Hearing Device Satisfaction Scale

0% 20% 60% 80% 100%

Vibrant Soundbridge Hearing Aid

Sound Quality of Own Speech

Naturalness of Speech

Clearness of Sound Tone

Overall Sound Quality

31%

27%

24%

89%

86%

86%

83%

40%

18%

0% 20% 40% 60% 80% 100%

Background Noise

Cleaning and Maintenance

Overall Fit & Comfort 56%

54%

8%


98%

98%

67%

56%

54%

8%

98%

98%

67%

Hearing Device Satisfaction Scale

0% 20% 40% 60% 80% 100%


Television

Theater

Movies

Enjoyment of Music

27%

20%

13%

29%

80%

86%

82%

78%

Satisfaction in Specific Listening Environments

implantable course 2015 med el

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