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The Sophono bone-conduction system: Surgical,

audiologic, and quality-of-life outcomes
By Timothy Mclean, MBBS; Irumee Pai, FRCS; Andrew Philipatos, BSc;
Michael Gordon, FRACS

Introduction
Bone-anchored hearing aids (BAHAs) have been in use for more than 30 years.1,2 Their efficacy in
the management of hearing-impaired patients with a mixed or conductive hearing loss who are
unable to use conventional hearing aids has been well established.3

The early percutaneous devices (Baha; Cochlear; Sydney, Australia, and Ponto; Oticon; Smrum,
Denmark) propagate sound through an osseointegrated implant.1 Indications for these devices
include malformations of the middle and external ear, chronic discharge, ossicular chain disease,
and single-sided deafness.4 There are, however, a number of drawbacks to the percutaneous
devices.

The most common implant complication is a periabutment soft-tissue reaction, as classified by

Holgers et al.5 Other complications include chronic pain, infection, and implant loss.4 In a study of
more than 1,000 implants, Dun et al found an implant loss rate of 8.3% over an average of 10 years
of follow-up.6

The next advancement was transcutaneous BAHAs, which conduct sounds by magnetic coupling
across intact skin.7,8 Their indications are similar to those of the percutaneous devices, but they
have different advantages and disadvantages. For example, transcutaneous devices require no
skin-penetrating abutment, so the risk of skin complications and implant loss is reduced.7,8

Audiologic outcomes with transcutaneous devices reported in the literature have been variable;
they appear to depend on the type of hearing loss.8-10 On the other hand, transcutaneous bone-
conduction systems have been shown to result in less functional gain (FG) than the
osseointegrated percutaneous devices; this is attributable to skin attenuation.7,10

One of the transcutaneous implants currently available is the Sophono system (Medtronic; Boulder,
Colo.) developed by Siegert.7 This system consists of a surgically implanted plate that contains
two magnets affixed to the skull and an external sound processor that houses a bone oscillator
and a metal disc. This arrangement allows for magnetic coupling of the internal and external
components across intact skin.

In this article, we describe our study of the surgical, audiologic, and quality-of-life outcomes with
the use of the Sophono implant.
Patients and methods
We prospectively studied 5 patients-2 men and 3 women, aged 22 to 64 years (mean: 41.8)-who
were implanted with a Sophono Alpha 2 MPO Processor from May 2012 through April 2013 (table
1). The surgeries were carried out by a single surgeon (M.G.) at two institutions, the Monash
Medical Centre and the Masada Private Hospital, both in Melbourne, Australia.

Table 1. Patient characteristics

Preop hearing aid
Pt. Age*/sex Type of hearing loss Indication
status

Single-sided deafness on
Single-sided
1 38/M the implant side, mixed Unaided
deafness
loss on the other

Recurrent ear canal

Conventional
2 22/F Mixed infections with
hearing aid
hearing aids

Recurrent ear canal

Conventional
3 63/F Conductive infections with
hearing aid
hearing aids

Conventional
4 64/F Mixed Patient preference
hearing aid

Recurrent ear canal Contralateral bone-

5 22M Mixed infections with anchored hearing
hearing aids aid

* Age (yr) at
the time of
surgery.

Outcomes measures included surgical complications, FG, speech discrimination in quiet and
noise, and quality of life.

Audiologic assessments. Audiologic testing was carried out by a single audiologist (A.P.)
preoperatively and again postoperatively at the time of activation. Pure-tone thresholds for air and
bone conduction were measured at 0.5, 1, 2, and 4 Hz pre- and postoperatively. The implant was
activated about 6 weeks after surgery (range: 35 to 58 days; mean: 45).

The first postoperative soundfield testing with warble tone was conducted with the sound
presented at an azimuth of 0 in the Sophono-aided condition. The FG provided by the Sophono
device was calculated by subtracting the optimally aided soundfield threshold from the unaided
postoperative pure-tone air-conduction threshold at each frequency.

Speech discrimination testing was performed with AB (Arthur Boothroyd) word lists in both quiet
and noise at 60 dB SPL, and comparisons were made between the pre- and postoperative scores.
The testing conditions were kept as close as possible to each patient's usual aided status in
everyday life, especially for the contralateral ear, which was either unaided or aided with a
conventional hearing aid or a BAHA.

Subjective assessments. Quality of life was determined by the results of the Glasgow Benefit
Inventory (GBI) and the Entific Medical Systems bone-anchored hearing aid questionnaire (BAQ):

The GBI is designed to gauge changes in health status that occur as a result of a surgical
intervention. It consists of three subscales: general (6 items), social (3 items), and physical (3
items). There are 5 possible responses to each subscale question. Results are based on the
total score, which ranges from -100 (no benefit) to +100 (maximum benefit).

The BAQ includes two sections, preoperative and postoperative. The preoperative section
consists of 12 items relating to qualitative and quantitative aspects of a patient's hearing
status at baseline. The postoperative section contains 8 items regarding the results of
implantation. In both cases, patients rate their satisfaction with their hearing device on a scale
of 1 (very unsatisfied) to 10 (very satisfied).

With both assessment tools, postoperative tests were administered after at least 2 weeks of
consistent device use.

Surgical technique. For implantation of the Sophono device, a curvilinear incision line was marked
posterosuperior to the pinna (figure 1, A). After infiltration of local anesthesia, an incision was
made down to and including the pericranium. An anteriorly based flap was elevated, and the
position of the implant was marked. A double well was then drilled into the skull cortex (figure 1, B)
to accommodate the twin-magnet implant (figure 1, C). The implant was then secured into place
with five self-drilling screws.

Figure 1. A: The surgical site is marked. B: The

surgical bed is prepared for implantation. C: The
implant is placed. D: The surgical site is healed.
The flap was replaced and the wound was closed in layers. Once the wound and flap healed (figure
1, D), the electronic sound processor and external magnet were loaded, usually about 4 weeks
after surgery.

Results
Preoperative findings. All patients had a bilateral hearing loss, the severity of which varied among
patients. One of the 5 patients had single-sided deafness on the implanted side and a mild mixed
hearing loss in the other ear (patient 1); he was unaided. Three patients had a bilateral mixed
hearing loss (patients 2, 4, and 5); 2 of them used a conventional hearing aid in both ears, while the
third had a BAHA on the contralateral side only. Finally, 1 patient had a bilateral conductive hearing
loss (patient 3); she used a conventional hearing aid in both ears. The indications for Sophono
implantation included recurrent ear canal infections (n = 3), single-sided deafness (n = 1), patient
preference in view of difficulty using a conventional hearing aid (n = 1) (table 1).

Preoperatively, the patient with single-sided deafness had a mean air-conduction threshold of 28.8
dB HL and a mean bone-conduction threshold of 18.8 dB HL in the contralateral ear. In the 3
patients with a bilateral mixed hearing loss, the mean preoperative air-conduction threshold was
60.0 dB HL (range: 52.5 to 72.5) and the mean bone-conduction threshold was 30.0 dB HL (range:
23.8 to 36.3) on the implanted side. The patient with the bilateral conductive loss had a mean air-
conduction threshold of 53.8 dB HL and a mean bone-conduction threshold of 20.0 dB HL on the
implanted side (table 2).

Table 2. Preoperative audiology

Implanted Contralateral
side side

Mean AC Mean BC Mean AC Mean BC

Pt. ABG ABG
threshold threshold threshold threshold

1 >107.5 >65.0 N/A 28.8 18.8 10.0

2 52.5 23.8 28.7 60.0 17.5 42.5

3 53.8 20.0 33.8 40.0 20.0 20.0

4 72.5 36.3 36.2 37.5 26.3 11.2

5 55.0 30.0 25.0 53.8 31.3 22.5

Key: AC = air conduction; BC

= bone conduction; ABG =
air-bone gap; N/A = not
applicable

Surgical complications. We observed no major surgical complications. One patient experienced a

minor skin reaction and pain in the early postoperative period, which both resolved with
conservative management.

Functional gain. The FG for the patient with single-sided deafness could not be calculated because
of the nature of his hearing loss. However, he did experience an improvement in soundfield
thresholds of 25, 10, and 5 dB at 0.5, 1, and 2 kHz, respectively.

In the 3 patients with a mixed hearing loss, the mean FG was 13.3, 20.0, 11.7, and 11.7 dB at 0.5, 1,
2, and 4 kHz respectively. The mean across all four frequencies was 14.2 dB (table 3).

Table 3. Functional gain after Sophono implantation

in patients with bilateral hearing loss
0.5 1 2 4
Pt. Type of hearing loss
kHz kHz kHz kHz

Single-sided deafness on
1* implant side, mixed loss on N/A N/A N/A N/A
the other

2 Mixed 15 20 15 15

3 Conductive 10 25 10 15

4 Mixed 10 20 10 5

5 Mixed 15 20 10 15

Mean 12.5 21.3 11.3 12.5

* Functional gain could not be

calculated because of the nature of
the hearing loss.

In the patient with bilateral conductive hearing loss, the FG was 10, 25, 10, and 15 dB at 0.5, 1, 2,
and 4 kHz. The mean across all frequencies was 15.0 dB (table 3).

Among the 4 patients with a bilateral mixed or conductive hearing loss, the mean FG across all
frequencies was 14.4 dB, with little difference between the mixed and conductive hearing loss
patients.

Speech discrimination. In all 5 patients, the postoperative Sophono-aided speech discrimination

scores as assessed with the AB word list were comparable to the preoperative scores in both quiet
and noise, although performance deteriorated with increasing background noise (figure 2).

Figure 2. Graph shows the pre- and postoperative

speech discrimination scores at 60 dB SPL according
to the AB words test in the 5 patients.
Subjective assessments. The mean GBI scores in the three subscales (general, social, and
physical) were +29.2, +13.3, and +20.0, respectively, and the mean total score was +24.4 (table 4).
All patients reported an overall positive outcome, with the most improvement seen in the general
subscale.

Table 4. Glasgow Benefit Inventory scores

Pt. General Social Physical Total

1 16.6 0 0 11.1

2 66.7 0 66.7 55.6

3 0 0 16.7 2.7

4 20.8 16.7 0 16.7

5 41.7 50 16.7 36.1

Mean 29.2 13.3 20.0 24.4

The preoperative BAQ scores were mixed, with some patients reporting that their conventional
hearing aids were difficult to use, uncomfortable, and not very helpful, while others found them
easy to use and invaluable. Postoperatively, 2 patients found that speech discrimination
improved with the implant while the other 3 said it had not changed. Four patients believed that the
aesthetics had improved while 1 felt that they were worse. Two patients found that usability
improved and 3 said it was no different from the old device. The average global satisfaction BAQ
scores were 6.2 of a possible 10 for the preoperative aided condition and 7.4 with the Sophono
implant.

Throughout follow-up, all patients remained satisfied with their implant and said that they wore
their device every day for more than 8 hours.

Discussion
We observed only one minor transient postoperative complication with the Sophono device, which
is consistent with similarly low complication rates published in the literature. In a study by Siegert,
the originator of the device, about 4% of patients developed temporary pressure areas, which were
resolved by adjusting the magnet strength.7 According to that report, patients expressed overall
improvements in comfort and safety compared with percutaneous devices. Sylvester et al also
found a low complication rate, as 10% of their patients experienced a minor skin irritation that
resolved with magnet adjustment.8

In contrast, percutaneous BAHAs are associated with much higher complication rates. In a study
of more than 600 BAHAs, Hobson et al reported an overall complication rate of 23.9%.11 Revision
surgery was required in 12.1% of cases. Their findings were well within the complication rates of 8
to 59% they found in the literature.

Overall, the audiologic outcomes for patients using the Sophono device in our study were positive.
The 3 patients with a bilateral mixed hearing loss had a mean FG of 14.2 dB across all frequencies,
which was greater than the 6 dB reported by Sylvester et al.8 Adding the 1 patient with a bilateral
conductive hearing loss, the mean FG across all frequencies for these 4 patients was 14.4 dB, with
little difference between mixed and conductive hearing loss patients. Sylvester et al reported a
mean FG of 22 dB in patients with conductive hearing loss, which was higher than that of the lone
patient in our study with a conductive loss (mean across all frequencies: 15.0 dB).8

In a case series of 6 children with congenital atresia, Denoyelle et al found that the FG with the
Sophono device was as high as 43 dB.9 In a study of 12 children, Hol et al compared the outcomes
of the Sophono device with those of the Baha device and concluded that while both systems
provided audiologic benefits, the Baha device yielded slightly better outcomes in terms of
soundfield thresholds, speech recognition threshold, and speech comprehension, and its output
was 10 to 15 dB higher.10

Most studies published to date have found that use of the Sophono system improved speech
discrimination or speech reception threshold relative to the unaided condition.8-10 In our study,
the speech discrimination outcome with Sophono was found to be at least comparable to that of
conventional hearing aids.

Our patients expressed overall satisfaction with the Sophono device, especially compared with
their previous hearing aid. Overall, their satisfaction score on the BAQ before and after
implantation rose from 6.2 to 7.4. We also found positive outcomes according to the GBI, with the
mean overall score of +24.4. This is similar to the positive results seen with respect to other ENT
operations measured by the GBI. For example, Gatehouse reported benefits of +24 after
rhinoplasty and +27 after tonsillectomy, with the latter reflecting an improvement but not complete
cure of symptoms.12 Similarly, Denoyelle et al found that children and parents were either satisfied
or very satisfied with the Sophono system.9

One notable case in this series was a 22-year-old man (patient 5) who was blind and who already
had a BAHA on the contralateral side. He reported that the Sophono processor was easier to place
than the BAHA, and that the lack of a percutaneous abutment that required daily maintenance was
a big advantage. His case illustrates the importance of assessing individual patients' capabilities
and taking into consideration any disabilities they may have when choosing an implant.

Our study had a number of limitations. The patient population was small, and the cohort was
heterogeneous, particularly with respect to the different types of hearing loss, which made it
difficult to draw any firm conclusions regarding each type of hearing loss. The hearing status of
the patient with single-sided deafness (patient 1) was slightly outside the implantation guidelines,
as the mean air-conduction threshold was 28.8 dB HL in his good-hearing ear. Nevertheless, we
believe that our rigorous prospective audiologic and quality-of-life data collection provides useful
information on this relatively new device.

We conclude that the Sophono Alpha 2 MPO Processor bone-conduction system is a safe and
efficacious option that should be considered in patients with a mixed or conductive hearing loss
who are unable to use a conventional hearing aid, as well as for those with single-sided deafness.
Transcutaneous stimulation has clear advantages over percutaneous stimulation in terms of
aesthetics and complication rates. It does, however, provide a lower audiologic output than a
BAHA, and it is therefore important to carefully consider both patient and audiologic factors for
best outcomes.

References
1. Tjellstrm A, Lindstrm J, Halln O ,et al. Osseointegrated titanium implants in the temporal
bone. A clinical study on bone-anchored hearing aids. Am J Otol 1981; 2 (4): 304-10.
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bone conduction devices: Skin reactions and implant survival. Otol Neurotol 2012; 33 (2):
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8. Sylvester DC, Gardner R, Reilly PG ,et al. Audiologic and surgical outcomes of a novel,
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9. Denoyelle F, Leboulanger N, Coudert C ,et al. New closed skin bone-anchored implant:
Preliminary results in 6 children with ear atresia. Otol Neurotol 2013; 34 (2): 275-81.
10. Hol MK, Nelissen RC, Agterberg MJ ,et al. Comparison between a new implantable
transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol
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11. Hobson JC, Roper AJ, Andrew R ,et al. Complications of bone-anchored hearing aid
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Previous presentation: A preliminary version of this research was presented at the 29th Politzer
Society Meeting; Nov. 14-16 2013; Antalya, Turkey. That version has been updated and edited for
publication.

From the Department of Otolaryngology-Head and Neck Surgery, Monash Medical Centre, Clayton,
Melbourne, Australia (Dr. Mclean, Dr. Pai, and Dr. Gordon); and Clearer Hearing Audiology, Kew,
Melbourne (Mr. Philipatos). The surgical procedures described in this study were performed at the
Monash Medical Centre and the Masada Private Hospital in Melbourne, and the audiologic testing
was conducted at Clearer Hearing Audiology.
Corresponding author: Timothy Mclean, MBBS, Department of Otolaryngology-Head and Neck
Surgery, Monash Medical Centre, 246 Clayton Rd., Clayton, VIC 3168, Australia. Email:
amcl8188@yahoo.com.au (mailto:amcl8188@yahoo.com.au)
Ear Nose Throat J. 2017 July;96(7):E28

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