Osseointegrated Auditory

D e v i c e s — Tr a n s c u t a n e o u s
Sophono and Baha Attract

a, b
Darius Kohan, MD *, Soha N. Ghossaini, MD

KEYWORDS
 Transcutaneous  Bone anchored  Osseointegrated  Sophono  Baha Attract

KEY POINTS
 Transcutaneous bone-anchored auditory implants are safe, effective, and cosmetically
acceptable, with low complication rates.
 Transcutaneous implants outcome as performed in both children and adults, provide up to
40dB gain, usually superior to Softband attached auditory processors.
 Percutaneous auditory implants generally provide 5 to 7 dB superior gain versus transcu-
taneous devices owing to direct coupling of processor to fixture/implant.
 Transcutaneous implantable auditory devices are MRI compatible; however, the Baha
Attract has an 11-cm shadow versus 5 cm for the Sophono.

INTRODUCTION

Percutaneous osseointegrated bone conduction implants, as noted by Soha N. Ghos-

saini and Pamela C. Roehm’s article, “Osseointegrated Auditory Devices: BAHA and
PONTO,” in this issue, are well-documented to be a very effective modality for auditory
rehabilitation in appropriate clinical settings. The main complications of percutaneous
devices are related to the inflammatory interaction between the abutment and sur-
rounding skin. In earlier studies, up to 30% of these patients had skin overgrowth or
infections at the abutment site. Many modifications and improvements have occurred
over time to ameliorate this problem; however, the cosmetic and psychological issue
of a “pin sticking out of one’s head” has not gone away. Transcutaneous osseointe-
grated devices were developed to address these issues.1 The Sophono system
(Sophono, Inc, Boulder, CO) was the first to develop this technology, soon to be fol-
lowed by the Baha Attract (Cochlear Ltd, Sydney, Australia). The acceptable medical

Disclosure Statement: D. Kohan: Medtronics- Principal investigator of Clinical trial comparing

Osseointegrated bone conduction devices 2014/15. S. Ghossaini: none.
a
Otolaryngology NYU School of Medicine, Northwell Health System, 863 Park Avenue,
Suite1E, New York, NY 10075, USA; b Otology- Neurotology, Ear Nose and Throat Associates of
New York, 35-30 Francis Lewis Boulevard, Auburndale, NY 11358, USA
* Corresponding author.
E-mail address: [email protected]

Otolaryngol Clin N Am 52 (2019) 253–263

https://doi.org/10.1016/j.otc.2018.11.013 oto.theclinics.com
0030-6665/19/ª 2018 Elsevier Inc. All rights reserved.
254 Kohan & Ghossaini

diagnoses by insurance carriers in the United States are the same regardless if
osseointegrated devices are transcutaneous or percutaneous (Box 1). The US Food
and Drug Administration-approved indications for the Sophono and Baha Attract
are the same (Box 2).

SOPHONO: MAGNETIC BONE CONDUCTION HEARING SYSTEM

The Sophono system consists of a titanium encased magnetic implant, a magnetic

spacer baseplate, and the Alpha 2 MPO sound processor. The magnetic implant is
the smallest on the market and lies completely under the skin. It consists of 2 magnets
hermetically sealed in a titanium case (Fig. 1).
Percutaneous devices transmit sound energy directly into bone via a sound processor
that is coupled to an implanted abutment screw. In this transcutaneous device, the
sound vibrations are transmitted via a baseplate to the skin, the implant magnet, and
the 5 osseointegrated maxillofacial screws securing the implant to bone, thus allowing
for bone conduction to the cochlea bilaterally. The size of the baseplate in contact
with the skin is important for maximum transfer of power to the bone. Transcutaneous
energy transfer technology may eliminate up to 20 dB of energy reflection on skin typi-
cally associated with percutaneous systems. The maximum acoustic gain is 45 dB. The
more direct energy transfer from processor to bone in percutaneous devices allows for a
5- to 7-dB theoretic gain advantage versus transcutaneous transmission (Figs. 2 and 3).1
The Sophono is cleared by the US Food and Drug Administration for MRI conditional up
to 3 T. The Sophono implant magnet produces a 5-cm shadow versus an 11-cm shadow
by the Baha Attract magnet, and in both systems magnet removal is not required.

Surgical Technique
The procedure may be performed under general anesthesia or monitored sedation
and should take about 30 to 45 minutes. A sterile template is provided with the implant
to facilitate flap design (Fig. 4).

Box 1
Acceptable medical diagnoses for osseointegrated implants (Baha, Ponto, SOPHONO):
International Classification of Disease codes

Anomalies
744.0: Anomalies of ear causing hearing impairment
744.23: Microtia
380.50: Acquired stenosis EAC
Infections:
380.02: Chronic perichondritis of pinna
380.14-6: Chronic otitis externa
380.53: Acquired stenosis EAC
381.1-4: Chronic serous otitis
382.0-01: Acute otitis media
385.3: Cholesteatoma
Hearing loss:
389.01-03 Conductive hearing loss
387 Otosclerosis
389.21-22: Mixed hearing loss
389.13: Single-sided deafness
Abbreviation: EAC, external auditory canal.

Courtesy of Andrea Vambutas, MD, Hempstead, NY.

 Osseointegrated Auditory Devices—Transcutaneous 255

Box 2
FDA-approved indications for transcutaneous osseointegrated devices

 Conductive hearing loss

 Mixed hearing loss
 SSD
 Age 5 to adult (implanted); all ages (headband/softband)
 45 dB bone conduction thresholds for indicated ear
 20 dB bone conduction thresholds in the better hearing ear (SSD)
Abbreviations: FDA, US Food and Drug Administration; SSD, single-sided deafness.

A semicircular incision is carried to the periosteum, which is elevated with the skin
flap. A template of the implant magnet is used to drill down 2 wells (2 mm deep) to
accommodate the implant, which must be secured in appropriate orientation with 5
maxillofacial screws of 3/4 mm length (Fig. 5).
An alternative that avoids bone drilling the 2 wells is to flip the magnet (sunny side
up; Fig. 6). The skin overlying magnet should be between 4 and 8 mm thick. The inci-
sion is closed in layers. The device is usually activated at 6 weeks when the edema of
the skin flap dissipated; however, if well-healed it may be activated as early as
3 weeks. The baseplate magnet comes in many different strengths to allow good
coupling of the processor without skin irritation.

Complications
Complications with transcutaneous devices are exceedingly rare and related to the
skin thickness over the implant. If too thin, patients report heat and discomfort wearing
processor and skin may breakdown exposing implant. This complication may be
addressed by decreasing the magnet strength of the baseplate. If the skin flap is
too thick and the processor is not well-attached to implant site, one can increase
the baseplate magnet strength to compensate. Revision surgery may also be indi-
cated to address patient dissatisfaction, worsening hearing, and device obsoles-
cence, as well as provide new and improved technology.

Fig. 1. Sophono implant magnet, baseplate magnet, and Alpha 2 MPO processor. (Courtesy
of Medtronic, Minneapolis, MN; with permission.)
256 Kohan & Ghossaini

Fig. 2. Differences between transcutaneous and percutaneous transfer of sound vibration

energy. Both put comparable energy into the temporal bone. The approaches differ, but
both get to the same place. (Courtesy of Medtronic, Minneapolis, MN; with permission.)

Data on pediatric transcutaneous implantable auditory devices are limited.

Denoyelle and colleagues2 in a prospective study in 15 children with atresia implanted
with the Sophono had no complications at all. Marsell and colleagues3 in a study on 6
children with the Sophono had 1 child with mild pain with prolonged use of device with
superficial ulceration that healed by lowering the baseplate magnet strength and with
local skin care.
Results
O’Niel4 studied the Sophono system in a pediatric population and concluded it was
equally effective to the other Bone conduction (BC) systems. Other publications
also found equivalent results among transcutaneous systems. A few studies
compared the different transcutaneous systems. In 2016 a study limited to 26 patients
comparing the Baha and Sophono systems, Kohan et al5 (pending publication)
concluded the percutaneous Baha with a #5 processor provided the best gain in
pure tone average, followed by the Sophono with the Alpha 2 MPO processor, and
the Baha Attract with a #5 processor (Kohan D, et al. Comparing hearing outcomes
in osseointegrated implantable auditory devices," poster presented at, COSM)5
(Table 1). The 6-dB pure tone average additional gain noted in the percutaneous rela-
tive to the best transcutaneous outcome is to be expected owing to the direct trans-
mission of vibratory energy with an abutment versus a transcutaneous device.6–8 The
gain at high frequencies drops off for all devices (Fig. 7). The Sophono Alpha 2 MPO
had the greatest percentage of gain achieved in pure tone average 4. Percutaneous
Baha devices had a greater percentage of gain achieved compared with their transcu-
taneous counterparts (Fig. 8).

THE BAHA ATTRACT OSSEOINTEGRATED SYSTEM

The Baha Attract System is a new, passive, transcutaneous auditory osseointegrated

device that was introduced into the market in 2013 in an attempt to overcome some of

Fig. 3. The difference in the 2 transcutaneous systems. The Sophono, on the left, uses a pro-
prietary transcutaneous energy transfer technology, whereas the Baha Attract (right) trans-
mits energy to a baseplate that is attached to a single osseointegrated screw. (Courtesy of
Medtronic, Minneapolis, MN; with permission.)
 Osseointegrated Auditory Devices—Transcutaneous 257

Fig. 4. SOPHONO surgical technique template localizes the incision site, length, and implant
position. (Courtesy of Medtronic, Minneapolis, MN; with permission.)

the skin complications and aesthetic concerns of its percutaneous counterpart. It in-
volves an osseointegrated titanium implant that is attached to an internal magnet. The
external sound processor fits on a sound processor magnet that connects to the inter-
nal magnet transcutaneously. Theoretically, the intervening skin layer may result in
less efficient sound transmission.9,10 This limitation can, however, be overcome to a
certain extent by the powerful sound processor in an auditory osseointegrated device
as shown by the positive results in the literature.11
The indications for Baha Attract are the same as for the percutaneous Baha. How-
ever, per manufacturer recommendation, patients with single-sided deafness with
large transcranial attenuation or hearing loss in the better hearing ear are better served
with the Baha Connect. The same Baha processors available for the Connect version

Fig. 5. Sophono surgical technique: operative photos. (A) Bone wells drilled into the bone
using a the male template provided in the implant kit. (B) Implant magnet in place. Five 4-
mm titanium screws are used for implant fixation. (Courtesy of Medtronic, Minneapolis, MN;
with permission.)
258 Kohan & Ghossaini

Fig. 6. Minimally invasive technique (sunny side up). No drilling is required; the device is
flipped. (Courtesy of Medtronic, Minneapolis, MN; with permission.)

of the device may also be used with the Attract, including the Power and Superpower
processor, depending on the patients presurgical auditory deficit.

Surgical Technique
Surgery can be performed under local or general anesthesia.12,13 The implant site is
identified using the template for Baha Attract ensuring that the sound processor
and its magnet are not touching the pinna. This placement usually corresponds with
a distance of 50 to 70 mm from the ear canal (Fig. 9). A C-shaped incision is marked
on the scalp 15 mm away from the edge of the magnet (Fig. 10). The surgical site is
prepared and sterilized. Before the injection of a local vasoconstrictive anesthetic, a
sterile needle is inserted to check the scalp thickness. Soft tissue reduction is per-
formed if the skin flap thickness is greater then 6 mm.
The skin incision is carried down to the periosteum and the flap is elevated. The
implant magnet template is used to check for proper positioning of the implant magnet

Table 1
Audiometric gain observed among osseointegrated implantable auditory devices

Sophono
Baha Baha Baha Baha Sophono Alpha 2
Connect Connect Attract Attract Alpha 2 MPO
#4 Processor #5 Processor #4 Processor #5 Processor Processor Processor
(dB) (dB) (dB) (dB) (dB) (dB)
PTA4 unaided 79 96 77 81 76 77
implant ear
PTA4 unaided 28 22 24 24 30 27
better ear (BC)
Max potential 51 74 53 57 46 50
gain PTA4
Average gain 31 49 22 35 35 43
Average 20 25 31 22 11 7
Res. ABG

Abbreviation: PTA4, pure tone average 4 (includes 4 frequencies: 500, 1000, 2000, 4000 Hz).
Courtesy of Darius Kohan, MD, New York, NY.
 Osseointegrated Auditory Devices—Transcutaneous 259

Fig. 7. Mean pure tone gain by device. All devices had a decrease in the mean gain at higher
frequencies (4000 Hz). Of the transcutaneous devices, the Sophono Alpha 2 MPO
had the least drop off. (Courtesy of Darius Kohan, MD, New York, NY; and Medtronic,
Minneapolis, MN.)

against the skin flap and the underlying bone. The central periosteum over the planned
implant site is incised in a cruciate pattern and elevated. The implant drill is used to
make a 3-mm deep well, and, if bone is palpated deep to that, a 4-mm implant drill
is used to extend that well medially by 1 mm. An appropriately deep (3 or 4 mm) coun-
tersink well is also drilled. All of this bony removal is performed using high-speed dril-
ling and copious irrigation. For single-stage implantation, the implant is secured using

Fig. 8. Mean pure tone average 4 (PTA4) tone gain by device. The Sophono Alpha 2 MPO
had the greatest percentage of gain achieved in PTA4. The percutaneous devices had
greater percentage of gain achieved compared with their transcutaneous counterparts.
(Courtesy of Darius Kohan, MD, New York, NY; and Medtronic, Minneapolis, MN.)
260 Kohan & Ghossaini

Fig. 9. The implant site usually corresponds with a distance of 50 to 70 mm from the ear ca-
nal. (Courtesy of Cochlear Limited, Sydney, Australia.)

the drill at lower torque, and irrigation after the first 2 turns to avoid excess heat to the
area. Then the bone bed indicator is used to ensure that there is enough clearance for
the implant magnet to sit flatly on the bone. If not, excess bone should be removed.
Then the implant magnet is attached to the implant. The incision line is closed, and
a pressure dressing is applied in Two-staged surgeries are indicated patients whose
cranial bone thickness is less than 3 mm or whose cranium has been irradiated. For
these patients, the implant is secured into the well to the appropriate depth available.
A cover screw, which prevents the ingrowth of soft tissue, is placed into the implant.
The second stage is performed 3 to 6 months later. At that time, the cover screw is
removed and the implant magnet is placed.
It is also feasible to switch the Baha Connect to the Baha Attract for either cosmetic
reasons or in patients with recurrent skin reactions from the percutaneous abutment.14
In a similar fashion, A C-shaped incision is designed around the preexisting abutment
making sure that it is 15 mm away from the edge of the magnet. The flap is elevated
down to periosteum. The abutment is removed and the implant magnet is secured to
the preexisting implant (Fig. 11). The flap is put back in position and adjacent tissue is
undermined to allow for primary closure of the incision. The resultant skin defect from

Fig. 10. A C-shaped incision is marked on the scalp 15 mm away from the edge of the mag-
net. (Courtesy of Cochlear Limited, Sydney, Australia.)
 Osseointegrated Auditory Devices—Transcutaneous 261

Fig. 11. Revision surgery from the Baha connect to attract. The Attract magnet is attached
to original implant in (B) after abutment is removed as seen in (A). (Courtesy of Cochlear
Limited, Sydney, Australia; and Sujana Chandrasekhar, MD, New York, NY.)

the site of the abutment is closed in a primary fashion if possible, or fascia or Alloderm
may be used if there is a sizable skin defect.
Audiological results with the Baha Attract system revealed improved thresholds
when compared with the unaided condition in most indications primarily in the speech
frequency range. The threshold improvement was noted to be less above the 3000 Hz
frequency. The audiological improvement postoperatively was comparable with the
Baha band test results, indicating that Baha band test results are a good indicator
of patient’s benefit.11
In a recent multicenter study, Hougaard and colleagues,12 looking at the benefits of
Baha attract in 105 patients with conductive hearing loss/mixed hearing loss and
single-sided deafness, it was found that free field audiometric testing scores improved
mainly in the low and mid frequencies. Minimal improvements in the low and high fre-
quencies were noticed in the single-sided deafness application. There was no signif-
icant improvement in hearing in noise for both the conductive hearing loss/missed
hearing loss and the single-sided deafness group. Patients, however, reported subjec-
tive benefit with the device and small complication rate.
Dimitriadis and colleagues13 in 2017 studied 105 Baha Attract patients with conduc-
tive hearing loss/mixed hearing loss and single-sided deafness. Of those who filled out
the questionnaires, there was a significant improvement in patient-reported outcomes
using the Glasgow Benefit Inventory and the Client Oriented Scale of Improvement
for the adult population. A systematic review of the literature of Baha Attract patients
in 2016 revealed satisfactory audiological results.15 This review, however, looked for
average improvement in audiological test scores of all patients with different types of
hearing loss (conductive hearing loss/mixed hearing loss and single-sided deafness).
Iseri and colleagues1 in 2015 compared the performance of 21 patients with
conductive hearing loss with the percutaneous Baha with 16 patients with conductive
hearing loss with the transcutaneous Baha Attract. It was noted that audiometric re-
sults for both groups were equivalent. No statistically significant differences were
262 Kohan & Ghossaini

found in the frequency-specific hearing gains between the groups, but the gain for all
the frequencies was better in the percutaneous group with the most significant gain
seen at 4000 Hz. Speech reception threshold values, however, were statistically sig-
nificant between the groups favoring the percutaneous one.
Complications
In a review of the literature in 2017, Chen and colleagues16 reported that erythema and
pain at the implant site were most common (19%), with resolution of the symptoms in
most patients with a decrease in magnet strength. They also reported on 1 case of skin
necrosis that was thought to be caused by the use of a strong magnet. Subsequently,
the Baha was converted to a percutaneous device. To avoid similar complications,
these investigators recommended the use of weaker magnets with restricted daily
use in the initial fitting period. Two more cases of skin necrosis in primary Baha Attract
patients were later reported.17
Other reported complications include seroma or hematoma formation, numbness
around the area of the flap, swelling, and detachment of the sound processor from
the external magnet.15
It is important to note that the use of Baha Attract is to be avoided in patients
requiring repeated MRI evaluation of the internal auditory canal area owing to the
resultant artifact.

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