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\begin{document}

\title{Long-term hearing performance and soft tissue outcomes of Baha@ Attract
system in patients with bilateral congenital microtia in a single center}



\author[1]{Ying Chen}%
\author[1]{You-zhou Xie}%
\author[1]{Liu-Jie  Ren}%
\author[1]{Na Gao}%
\author[1]{Wen-xiu Gu}%
\author[1]{Chen-long Li}%
\author[1]{YAOYAO FU}%
\author[1]{Jun-li Zhang}%
\author[1]{Tian-yu Zhang}%
\affil[1]{Fudan University Eye Ear Nose and Throat Hospital}%


\vspace{-1em}



  
  \date{May 23, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Abstract: Background: Baha Attract System was designed as non-skin
penetrating bone conduction implant to minimize skin complication.
However, there were insufficient studies on its long-time acoustic
outcome and safety in microtia patients with auricle reconstruction
surgeries, who have thinner retroauricular subcutaneous layer and
theoretically vulnerable skin at the implant side. Objectives: To
analysis the long-term hearing performance and soft tissue complications
of Baha@ Attract System in microtia population. Study Design \& setting:
A prospective cohort study at single tertiary referral center. Patients:
Twenty Mandarin-speaking patients with congenital bilateral microtia who
were underwent Baha@ Attract implantation with or without auricle
reconstruction surgeries simultaneously. Main Outcome Measure(s):
Comparative analysis of audiological test results including hearing
thresholds and speech recognition in quiet and in noise were pre- and
post-operatively performed. subjective benefit as measured with the SSQ
Scale. Soft tissue outcomes were monitored and documented. Results: The
mean follow-up time was 36.11\selectlanguage{ngerman}±3.30 months. Significant and stable
improvements in hearing threshold and speech understanding in noise and
quiet were demonstrated with aided condition. Subject evaluation
revealed high level of patients' satisfaction with the amplification in
all the subscales. Adverse events including skin necrosis increased
after one year post-operatively. Soft tissue evolution including sin
thinning, erythema, epidermis atrophy, soft tissue atrophy, skin
necrosis was seen or once developed in most of the participants.
However, prevalence of severe soft tissue complication was not higher to
non-microtia population. Conclusions: Baha@ Attract System provides
favorable and stable hearing improvements for microtia patients.
Combining plastic surgeries with implantation will not increase the
prevalence of soft tissue complication. However, long-term soft tissue
problems should be highly aware of even after one year post
implantation. Key words: Baha Attract, microtia, hearing, soft tissue,
skin necrosis%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{Long-term hearing performance and soft tissue outcomes of
Baha\textsuperscript{@} Attract system in patients with bilateral
congenital microtia in a single center}

\textbf{Abstract:}

\textbf{Background:} Baha Attract System was designed as non-skin
penetrating bone conduction implant to minimize skin complication.
However, there were insufficient studies on its long-time acoustic
outcome and safety in microtia patients with auricle reconstruction
surgeries, who have thinner retroauricular subcutaneous layer and
theoretically vulnerable skin at the implant side.

\textbf{Objectives:~} To analysis the long-term hearing performance and
soft tissue complications of Baha\textsuperscript{@} Attract System in
microtia population.

\textbf{Study Design \& setting:} A prospective cohort study at single
tertiary referral center.

\textbf{Patients:} Twenty Mandarin-speaking patients with congenital
bilateral microtia who were underwent Baha\textsuperscript{@} Attract
implantation with or without auricle reconstruction surgeries
simultaneously.

\textbf{Main Outcome Measure(s):} Comparative analysis of audiological
test results including hearing thresholds and speech recognition in
quiet and in noise were pre- and post-operatively performed. subjective
benefit as measured with the SSQ Scale. Soft tissue outcomes were
monitored and documented.

\textbf{Results} : The mean follow-up time was 36.11\selectlanguage{ngerman}±3.30 months.
Significant and stable improvements in hearing threshold and speech
understanding in noise and quiet were demonstrated with aided condition.
Subject evaluation revealed high level of patients' satisfaction with
the amplification in all the subscales. Adverse events including skin
necrosis increased after one year post-operatively. Soft tissue
evolution including sin thinning, erythema, epidermis atrophy, soft
tissue atrophy, skin necrosis was seen or once developed in most of the
participants. However, prevalence of severe soft tissue complication was
not higher to non-microtia population.

\textbf{Conclusions:} ~Baha\textsuperscript{@} Attract System provides
favorable and stable hearing improvements for microtia patients.
Combining plastic surgeries with implantation will not increase the
prevalence of soft tissue complication. However, long-term soft tissue
problems should be highly aware of even after one year post
implantation.

\textbf{Key words:} Baha Attract, microtia, hearing, soft tissue, skin
necrosis

\textbf{Key points:}

\textbf{1.} Baha\textsuperscript{@} Attract System can provide effective
and stable hearing amplification for microtia patients.

\textbf{2.} Concurrent surgeries of auricle reconstruction and
Baha\textsuperscript{@} Attract implantation will not bring additional
risk in terms of soft tissue complications.

\textbf{3} .Adevese events increased with the duration of the
implantation, even one year post surgery.

\textbf{4.} Benign skin evolution including skin thinning, erythema at
the implant side is commonly seen in Baha\textsuperscript{@} Attract
users and need to be aware of.

\textbf{5.} Implant is not necessarily removed when skin necrosis occurs
in Baha\textsuperscript{@} Attract users.

\textbf{1.Introduction}

Microtia is a common congenital malformation which can causes conductive
or mix hearing loss. Hearing rehabilitation by meatoplasty and
tympanoplasty for patients with microtia and atresia remains a great
challenge for otologists due to the complex anatomy and potential
complications. Only patients with Jahrsdoerfer grading 6 or higher are
suitable candidates for tympanoplasty(1).

Bone conduction implants (BCIs) can be considered as alternation for
hearing restore for microtia(2). Bone Anchored Hearing Aid (BAHA), as a
representative percutaneous BCI, has been widely implanted in microtia
with atresia cases. Common complications regarding to skin reactions
were reported at a high rate of up to \textasciitilde{}30\% due to its
percutaneous abutment(3). Non-skin penetrating BCIs were designed to
avoid the disadvantages of the percutaneous type.
Baha\textsuperscript{@} Attract System was the late-launched
transcutaneous BCI in 2013. Several studies have proved the efficiency
of this system and the advantage of less soft tissue complications(4).
It has been reported the Baha\textsuperscript{@} Attract System
implantation could be performed simultaneously with microtia auricular
reconstruction(5).

Unlike other hearing impairment population, patients with bilateral
microtia ideally should get early audiological intervention during
childhood to meet the demands of speech development. Meanwhile, microtia
usually occurred with the concomitnta dysplasia of the mandibular bone
and temporal bone, resulting to a low volume of mastoid and tympanum
pneumatization(6). During the concurrent surgery of auricular
reconstruction and hearing aids implantation when the candidate was six
years or older, taking the mastoid volume for holding the implant into
account, it's wisely to adopt a comparably small implant. To this
extend, Baha\textsuperscript{@} Attract System is more suitable to be
implanted in order to avoid possible compression of the sigmoid sinus
and meninges during the implantation(6).

Moreover, the safety of skin needs to be identified by clinical
observation, when the subcutaneous retroauricular fascial \selectlanguage{english}flap was
rotated during the simultaneous surgery, leading to thinner subcutaneous
layer and theoretically vulnerable skin at the implant side. This study
reported long term soft tissue outcomes as with as hearing performance
of Baha\textsuperscript{@} Attract implant, aiming to provide solid
evidence to the current knowledge.

\textbf{2.Method and material}

The current manuscript was prepared with STROBE checklist.

\textbf{2.1 Ethical standards}

This study was approved by the local ethical committee and was conducted
in accordance with the ethical standards of the 1964 Declaration of
Helsinki. Informed consent was obtained from all individual participants
or their supervisors before recruitment.

\textbf{2.2 Study design}

Single-center prospective cohort study. Patients served as their own
controls.

\textbf{2.3 Patience and device}

Bilateral microtia patients with an indication for a bone conduction
hearing implant in this study were recruited from 2017/7/1-2018/3/1. All
recipients should meet audiological eligibility. Test device was the
Baha\textsuperscript{@} Attract System (Cochlear Bone Anchored Solutions
AB, Molnlycke, Sweden) with Baha 5 sound processor (SP). Test
osseointegration implant was BI300 Implant on which BIM400 Implant
Magnet was fixed. Strengths of SP magnets available for participants
vary from the strongest (No.6) to the weakest (No.1) to provide
sufficient retention.

\textbf{2.4 Surgery}

Implantation was performed solely or integrated with staged auricle
reconstruction (framework projection) for microtia simultaneously under
general anesthesia. During integrated surgeries, incision 5mm outside
the posterior margin of the reconstructed auricle was made first,
super\selectlanguage{english}ficial layer of the fascia covering the dorsal part of reconstructed
auricle was dissected to the posterior edge of the cavum conchae, the
retroauricular fascial \selectlanguage{english}flap 20mm behind the incision was dissected and
lifted to match the expected cranioauricular sulcus(7). With lifting of
the retroauricular fascia, the periosteum at implant site could be
sufficiently exposed, causing thin soft tissue layer above the implant.
Then the BI300 was implanted in a standard surgical procedure, soft
tissue reduction was performed if the flap thickness was more than
6mm(8). Following procedure was conducted as previously reported(7).

Four weeks post-operation, if the wound had healed, the Baha SP was
loaded though magnet coupling during first fitting. Afterwards, soft
tissue over the implant was evaluated and documented by same senior
surgeons.

\textbf{2.5 Audiometry and speech recognition test}

Audiometry was performed in a soundproof booth systematically at the
fist fitting, 3-,6-months and 3-years after fitting. Hearing threshold
was measured in free field test using warble tone. Speech recognition in
quiet and in noise were measured using Mandarin Speech Test Material. To
measure speech recognition in quiet, monosyllabic and disyllabic speech
discrimination test at 65 dB SPL were performed(9). For speech
recognition in noise, sentences consisted of 6-9 Chinese characters (6-9
syllables) and white noise at +5 or +10 dB signal--to-noise ratio (SNR)
were applied. All the test signals were presented to the front side of
the participants. Measurements were repeated 2-4 times and average
values were taken to avoid implementation bias.

\textbf{2.6 Subjective benefit}

The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire
was administered pre-and post-operatively to evaluate the subject
benefit in three subscales when using hearing amplification(10).

\textbf{2.7 Statistical analysis}

Results are presented as mean +- SD. Bone-conduction or air-conduction
pure tone average (BC/AC-PTA) was the mean of hearing thresholds on
frequency 0.5, 1, 2, 4 kHz. The hearing gain was meant as unaided PTA
minus aided PTA in the free field test. Statistical analysis was
conducted utilizing SPSS (SPSS Inc., Chicago, USA, v22.0). P values of
\textless{}0.05 were considered as statistically significant.

\textbf{3.Results}

\textbf{3.1 Demography}

Twenty Mandarin speaking patients (18 males and 2 females) were
recruited, including two mix hearing loss patients and 18 cases with
conductive hearing loss. Mean age during implantation was 14.67+-6.02,
ranging from 8 to 30 years old. Clinical follow-up was completed in 18
patients (90\%) with a mean duration of 36.11+-3.30 months(31-44months),
among which 16 cases underwent final audiological assessment. Two
patients (10\%) were lost to follow-up 6 months post fitting.

\textbf{3.2 Baseline hearing}

Baseline audiometry revealed an average BC-PTA of 16.0 +- 7.21 dB HL of
the implanted ears, ranging from 1.25 - 32.50 dB HL, and an average
AC-PTA of 75.1 +- 12.63 dB HL. Baseline hearing thresholds in frequencies
are showed in Figure 1.

\textbf{3.3 Surgery and wound healing}

Perioperative period was uneventful except that one girl (No.4 patient)
was found hematoma 6 days post-operatively, and recovered after hematoma
puncture and compression bandage. Integrated surgery was performed in 16
patients, the remaining 4 patients underwent implantation only, among
them 2 cases completed auricle reconstruction surgeries previously.
Sound Processors were firstly switched on as scheduled one month after
surgeries in all participants.

\textbf{3.4 Skin thinness and magnet}

Soft tissue reduction was applied in one patient from 8mm to 6mm. Mean
skin thickness was 4.63+-1.14mm at the implant sides. During the first
half year, a trend of downgrading the magnets during follow-up was
observed (Table 1). One patient suffered from insufficient retention
force around 2 years after integrated surgery, which was solved by
changing into stronger magnet. B-ultrasound examination showed scar
tissue grew near his implant, resulting in different soft tissue
thickness above the implant.

\textbf{3.5 Audiometry} \textbf{results}

Mean AC hearing thresholds in the free field test on each frequency by
visit are shown in Figure 2A. AC hearing threshold averages with
softband or implants improved significantly compared to the unaided
condition in all frequencies (p\selectlanguage{english}<0.001). The unaided-AC PTA was 59.43 +-
4.54 dB SPL, which decrease to a aided PTA of 24.94+- 3.76 dB
SPL\selectlanguage{english}(n=20\selectlanguage{english}), 25.31 +- 3.76 dB SPL\selectlanguage{english}(n=20\selectlanguage{english})and 27.34+-9.28 dB SPL\selectlanguage{english}(n=16\selectlanguage{english})at
3,6 months and 3 years, respectively. No statistical differences in PTA
compared with each two results was recorded. Comparing PTA between
unaided and aided hearing at 6 months, a hearing gain of 34.13+-4.97 dB
was achieved. A maximum hearing gain of 44.75+-5.73 dB was observed in
the frequency of 1 kHz (Figure 2B).

The result of the speech recognition score in quiet and noise is
summarized in Figure 2C. The aided score showed significant improvements
in all conditions compared with unaided hearing (p\textless{}0.001).
Notably, monosyllabic and disyllabic WRS average when aided by implants
(3 year) were significantly better than by softband (p\textless{}0.05).

\textbf{3.6 Subjective benefit}

Patient- or parents-reported SSQ questionnaires showed a significant
improvement between unaided and aided conditions in speech
(p\textless{}0.05), spatial (p\textless{}0.05), and quality
(p\textless{}0.05) (Figure 2D). A gross score of 6.36 in 6 months
post-fitting was achieved, which was significantly better than the
pre-operative~score of 4.44 (p\selectlanguage{english}<0.001).

\textbf{3. 7 Adverse events and soft tissue outcomes}

Adverse events were definite as soft tissue or skin complication that
made users stop using the devices, which increased from 4 cases at 6
months to 13 cases at 3 years (Table 2). Most of the adverse events were
minimal and recovered without medical intervention.

However, two events were ranked as severe ones because of causing a
break of more than one month. One severe adverse event (SAE)was reported
about implant exposure and infection in No.4 patient 2 years after
surgery (Figure 3A). Infection was rapidly controlled with conservative
treatment (including appropriate antibiotic treatment, daily rinse with
hydrogen peroxide and ofloxacin). The subcutaneous tissue but not the
skin re-grew to cover the implant, so a surgical debridement and skin
flap transposition was performed to cover the uneven surface 4 months
later. Afterwards, it took another 2 months after reverse surgery for
the patient to re-use the device with a gradually increasing duration,
varied from 5 to 11 hours per day. Numbness occurred after long duration
of device wearing in decreasing frequency and severity. Audiometry
evaluation revealed that the implant system still yielded a good
performance in aided condition.

The other SAE happened in No.21 patient who developed extreme soft
tissue atrophy after wearing his magnet system without softpad. A
Softband was applied for 1.5 months until the patient recovered (Figure
3B).

In the last re-visit, soft tissue and skin modification or complication
was seen in 72.2\% (13/18) patients included soft tissue thinning,
erythema, epidermis atrophy, and local hair loss that did no need
further treatment (Table 2, Figure 3C-H). During the whole study, 4 out
of 18 patients experienced no skin irrigation, pain, numbness or other
adverse events even these patients continuously used the devices.

\textbf{3.8 Duration of daily use}

At the end, all patients benefited from their devices. The girl
recovered from implant exposure was still increasing the time of using
the magnet system. The remaining patients reported regular use of the
devices in all waken hours varied from 8 to 16 hours.

\textbf{4.Discussion}

\textbf{4.1 Synopsis of key findings}

The current study demonstrated the effective and stable hearing
amplification of Baha\textsuperscript{@} Attract System, and make an
alert by described high proportion of the long-term soft tissue
evolutions in its microtia users. Meanwhile, clinical experiences of
dealing with soft tissue problem including skin necrosis were provided
for health care providers.

\textbf{4.2 Limitations and strengths}

This study was a single-center prospective trial. With longer
follow-ups, the authors showed the unreported soft tissue evolutions and
the corresponding treatment in the Baha\textsuperscript{@} Attract
users, which is the crucial for the soft tissue safety. However, the
sample size should be enlarged to increase the strengths of study.

\textbf{4.3 Compared to other studies}

\textbf{4.3.1 hearing outcomes}

Audiometry results confirmed that Baha\textsuperscript{@} Attract not
only provided a satisfactory, stable hearing gains for microtia
population, but also significantly improved speech recognition. The
hearing test results consisted with that of other studies on microtia
group, but were better than other studies including different
etiologies(5, 11-13). As previously reported, downgrading magnet force
without decreasing hearing gains was observed(14). The reason behind
might be the gradually thinning of skin on the implants side.

\textbf{4.3.2 Soft tissue safety}

Previous studies on the Baha\textsuperscript{@} Attract implantation
combined with auricle reconstruction reported no adverse events (5, 20).
However, most involved patients in these studies were followed up for no
more than 6 months post-fitting. A study with one year follow-up
reported skin thinning in Baha Attract users, but not fully elaborated
the prognosis (14).

In the current study, eliminating two dropout cases, less than 1/3
patients in our cohort were free of soft tissue evolution or
complications. Moreover, the proportion of patients with adverse events
increase from 20\%\selectlanguage{english}(4/20\selectlanguage{english})at 6 months to 55.6\% (10/18) at
\textasciitilde{}3 years post-operatively, which was much higher than
previously reviewed data(78.8\% users were free of skin complication)
(15). Although most of the complications were minuscule or reversible,
long term soft tissue complication should be aware of.

Another study by Nevoux reported high~proportion of skin evolution in 20
Baha\textsuperscript{@} Attract users (putative non-microtia population
with plastic surgeries) after following 2.9 +- 0.47 years (16). Nevoux
also proposed a three-grade classification of skin and soft tissue
evolution for Baha\textsuperscript{@} Attract(16). According to this
classification system, in our patients who underwent implantation and
auricle reconstruction simultaneously or separately(n=18), 4 cases
(patients developed soft tissue atrophy, epidermis atrophy, hair loss
respectively) could not be well classified, one patient went through
grade 3 soft tissue complication, the rest 13 cases were ranked as grade
0-1 evolution that need no intervention. Fisher exact test provided
there was no difference between these two cohorts in proportions of
patients with grade 0-1 skin reaction(p\selectlanguage{english}>0.05, 75\% cases in Nevoux's
group ). Furthermore, there were more patients undergoing salvage
surgeries in Nevoux's group (3 cases) compared to ours (1 case). The
above facts demonstrated implantation combined with auricle
reconstruction would not lead to higher prevalence of long-term
complications.

\textbf{4.3.3 Clinical treatments for skin necrosis in Baha}
\textsuperscript{@} \textbf{Attract users.}

Skin necrosis is the most severe complication leading to implant removal
in Baha Attract users. There were only two case of skin necrosis
previously reported by Chen and Nevoux, respectively(16, 17); In our
skin necrosis case, conservative and surgical treatment were taken to
maintain the implant. Many factors might play important role for the
success of treatment. Firstly, the titanium implant ensured good
biocompatibility(18); secondly, intensive care was administrated to
control infection; thirdly, pedicled flap that exceeded beyond the
boundary of implant magnet was made to guarantee its blood supplement;
Finally, long break before re-loading the external magnet and slowly
increasing the time of device wearing ensured the safety of the flap.
Our experience provided another way to treat skin necrosis in
Baha\textsuperscript{@} Attract users, yet had apparent disadvantages of
prolonged the unavailability of the magnet system. Medical decision
should be made according to patients' preference, predicted clinical
outcomes, health care resource and other socioeconomic factors.

\textbf{4.4 Clinical applicability}

The present study certified the long-term soft tissue safety of
Baha\textsuperscript{@} Attract in microtia patient underwent auricle
reconstruction and implantation simultaneously or separately, and
proposed that more attention should be taken for the soft tissue
evolution. Potential risk factors including overloading retention force,
wearing magnet system without softpad, or long duration of device using
without break should be avoided.

\textbf{5.Conclusion}

The investigated Baha\textsuperscript{@} Attract system benefits the
bilateral microtia patients by providing favorable and stable hearing
improvements. Integrated auricle reconstruction with implantation is
safe in terms of soft tissue reaction. However, long-term soft tissue
problems should be highly aware of even after one year post
implantation.

\textbf{Acknowledgement}

All the authors declared of no conflict of interest.

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2014;24(2):59-64.\selectlanguage{english}
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