Implantable Auditory Devices

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

Lenox Hill HospitalManhattan Eye, Ear, and Throat Hospital

New York CityNew York, NY

March 20, 2015

Implantable Auditory DevicesSophono

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 Sophono

Implantable Auditory Devices (IAD) – Why not a Hearing Aid?

• Inability to wear, tolerate or benefit from standard amplification

• Not cochlear implant candidate• Financial considerations

Indications for Bone Conduction Implants

Conductive or mixed hearing loss

BC threshold indication: ≤ 45 dB HL* Ideal candidates: BC ≤ 35 dB HL

Bilateral (symmetrically conductive or mixed-hearing loss). Difference between both sides’ BC ≤ 10dB on average* and ≤ 15 dB at any frequency.

SSD patients who will not or cannot use an AC CROS. PTA - AC in the good ear should be ≤ 20 dB HL*.

* Measured at 0.5, 1, 2 and 3 kHz

Transcutaneous Versus Percutaneous

      

BAHA® or PONTO ®

Processor

Percutaneous Abutment

Sophono®

Processor

Transcutaneous Magnet

Both put comparable energy into the temporal bone

The approaches differ… both get to the same place

The Way Sound Vibrations Travel

Sophono• Entire baseplate directly

transmits force to bone

T-BAHA• Baseplate force is indirect;

plate-to-disk-to-screw

• Skin will conduct sound (Force) and in certain frequencies skin will even amplify sound (Force)

• The size of the baseplate in contact with the skin is important for maximum transfer of power

to the bone

Force (Sound) Wave propagating in bone

Alpha 2Force Injected into skin

Magnetic Implant

Force (Sound) Wave propagating in bone

TETTM Technology

TETTM Technology

• Amplification / Attenuation by the skin

• Large baseplate/ skin interface

• Skin Amplification - 500Hz to 4kHz (Speech)

• Skin Conducts Sound (Force)

Bone Conduction Systems (To Scale)

Sophono® with TET™ BAHA® Transcutaneous

Med-El Bonebridge™ BAHA® Percutaneous

Bone Conduction Implants (To Scale)

BoneBridge

BAHA / Ponto

BAHA Transcutaneous

Sophono Alpha

Sophono with TETTM:with Transcutaneous Energy Transfersound energy tunnels through the skin

P-BAHA® and PontoTM devices:Sound energy enters abutment screw sticking through the skin

T-BAHA® device:Transcutaneous

BoneBridgeTM device:Sound energy is electrically generated in an implanted device

Sophono Surgical Technique

Sophono Template

Surgical Procedure

Bone Wells

Five 4 mm Self Tapping Screws Secure Implant

Sophono Template - Modified

Sophono Incision - Modified

Sunny Side Up Versus Classical

Sunny Side UP

Sunny Side UP

IAD Available in the USAOsseointegrated Devices:

• BAHA Connect• BAHA Attract• Ponto• Sophono

Bone Conduction Device: • Bonebridge – close to approval by FDA

Mechanically Driven Devices:• Vibrant Soundbridge• Maxum• Esteem

Other Alternatives: • Soundbite system

IAD - Which One to Select? • Indications between devices greatly overlap

• Each company promotes their product as the best and safest!• Similar dilemma as in CI options: which one is the safest, provides best

audition and reliability• Doctors and audiologist may guide patient based on patient

medical/auditory status • Consider financial factors and insurance coverage• Consider how available is the company support for their particular device• Does the surgical/audiology teem have the skill and knowhow for all

devices?• Does the patient really decide on IAD, or does the otologist/audiologist

make the decision for them?

Sophono Versus BAHA AttractAlpha 2 BAHA Attract

System Image

Minimum Age 5 years 5 years

Indicated Hearing Loss Conductive, Mixed, and SSD Conductive, Mixed, and SSD

Max Indicated BC Threshold for CHL BC better than 45 dB BC better than 30 dB

Required Good Ear THR in SSD BC better than 20 dB BC better than 20 dB

Published Complication Rate <4% Unknown

MRI Compatibility OK in MRI max 3T – 4.5 cm shadow OK in MRI max 1.5T – 11.5 cm shadow

Sophono Versus BAHA AttractAlpha 2 BAHA Attract

System Image

Osseointegration Time 1 week 4 weeks

Device Specific Surgical Kit No Yes

Time Between Surgery and 1st Fitting 4 weeks (potentially 1 week) 4 weeks (potentially 3 weeks)

Number of Frequencies 16 17

Number of Microphones 2 (adaptive directional, omnidirectional)

2 (adaptive directional, omnidirectional)

Battery Life 20 days (12 h/day) 1.5 days at 60 dB15 days silence (12 h/day)

Bluetooth Capability Needs Adaptor Internally Incorporated

Reviewed My Experience in IADFirst implant 1/2002 to present – patients >18 yo BAHA (classic) – all single stage procedures

• primary surgery – 78 patients – last 7/26/12• 2 patients returned to OR for flap revision• Revision surgery – 11 patients – last 3/11/11• Bilateral surgery – 2 patients – last 1/06/06

BAHA Attract – 22 patients – first 12/12/13• Revision surgery – 1 for flap failure

Ponto – 2 – last – 9/14/12Sophono – 16 patients – first 4/25/13Vibrant Soundbridge – 1 patient

Surgical Technique and Outcome

• Same surgeon, multiple institutions• All one stage procedures, ambulatory, monitored anesthesia except

Soundbridge• No intra or postoperative complications with any surgery• Late complications only in BAHA Connect

• 36% local skin recurring complications at abutment site: cellulitis, overgrowth

• Rx: topical/systemic antibiotics, abutment change in office to longer size, kenalog

• 2 revision flap surgery• 2 patients had trauma dislocating abutment needed revision surgery

Prospective Study Protocolwith Institution IRB Approval

• Select in chronologic reverse order 3 groups of 5 adult patients with either BAHA – Connect, BAHA – Attract, or Sophono

• Comprehensive audiogram – AC, BC, SRT (spondee words), SDS (CID word list) – recorded speech-note: better ear was properly masked

• Unaided and aided Sound Field testing• Speech in noise – QuickSIN test• Abbreviated Profile of Hearing Aid Benefit test- APHAB

Demographics

Demographics n=5 Mean Age Mean Duration Use (mo)

Sophono 5 66.4 13

BAHA Attract 5 48.6 7.8

BAHA Connect 5 66.2 44.8

BAHA Connect PopulationPatient

Etiology of Hearing Loss

Hearing Loss – SDS (%) Unaided PTA

Air Bone Gap

Gain

RB AS- Meniere’s AD-mod HF SNHL-100AS-SSD-24 AS- 76dB 70dB 30dB

JB AS-Cholesteatoma AD-WNL-100AS-max CHL -100 AS-66dB 52dB 38dB

JK AU-CholesteatomaAU-MRM

AD-sev MHL-84AS-mod CHL-96

AD-65dB 36dB 31dB

WC AD-SSNHLAU-sev eczema

AD-sev SNHL-80AS-mild presby-92

AD-65dB 26dB 23dB

MC AD-cholesteatoma AS-COM

AD-prof.SNHL-0AS-sev MHL-88

AD-80dB 37dB 31dB

BAHA Attract PopulationPatient

Etiology of Hearing Loss

Hearing Loss – SDS (%) Sound Field Unaided PTA

Air Bone Gap

Gain

BJ AS-cholesteatoma

AD-WNL-100AS-max CHL-100 AS-74dB 68dB 30dB

JG AS-Meniere’s AD-WNL-100AS-prof SNHL-16 AS-80dB 69dB 20dB

GM AU-COM AD-HF sev SNHL-88AS-M/S to sev MHL-84 AS-69dB 37dB 21dB

WT Nasoph. Ca/RT AD-M/S MHL-96AS-sev MHL-0

AD-65dB 35dB 15dB

BP AU Wide Vest. Aq.

AD-mild/mod SNHL-96AS-prof SNHL-0 AS-86dB 55dB 23dB

Sophono PopulationPatient Etiology of

Hearing LossHearing Loss – SDS (%) Sound Field

Unaided PTAAir Bone Gap

Gain

LG AU-COM AU-sev CHL-92 AS-64dB 35dB 29dB

JMG AU-post fenestration

AU-prof mix HL-AD-12 AS-96

AD-89dB 34dB 19dB

RH AD-Meniere’s AD-prof SNHL-0AS-mild SNHL-80

AD-69dB 45dB 31dB

MT (1) AS-COM AD-HF mild SNHL-96AS-sev MHL-92 AS-64dB 30dB 24dB

MT AU-cholesteatoma

AU –max CHL-100 AD-58dB 47dB 34dB

Comparison

BAHA Connect BAHA Attract Sophono

PTA unaided 70.4dB 74.8dB 68.8dB

BC threshold 26dB 22.3dB 30.5dB

Air bone gap 44.4dB 52.6dB 38.3dB

Gain (STDV) 30.5dB (5.3) 21.8dB (5.4) 27.25dB (5.9)

Res. ABG 13.9dB (15.1) 30.8dB (13.5) 11.1dB (4.2)

500 1000 2000 40000

5

10

15

20

25

30

35

40

Mean Pure Tone Frequency Gain by Device

Sophono (n=5)

BAHA Attract (n=5)

BAHA Connect (n=5)

Frequency (Hz)

dB

Sophono BAHA Attract BAHA Connect

-5

0

5

10

15

20

25

30

APHAB: Ease of Communication ScaleSc

ores

(%)

Preliminary Conclusions

• All studies devices were easy to insert in less than 30 minutes• No operative complications• Late local complications with the BAHA Connect are common• All device options provide patient benefit• Percutaneous Baha Connect provides the best PTA gain of 31dB• Transcutaneous Sophono provides on average 6 dB better PTA gain vs. Baha

Attract• Gain at high frequencies drops off for all devices, the least decline for

Sophono