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Cochlear Baha Attract System: Summary of clinical results and benefits

Technical Report · June 2014

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Cochlear™ Baha® Attract System

Summary of clinical results and benefits

Mark C. Flynn, PhD

In 2013, Cochlear introduced the Cochlear™ Baha® Attract System*. This paper summarises the key pre-clinical
investigations, multicentre clinical investigation and the post-market follow-up of the system. The pre-clinical technical
research established that using a single-point of sound transmission facilitated efficient transfer of sound through the bone
to the cochlea. In addition, the use of the unique Baha SoftWear™ pad** ensured that pressure could be evenly distributed
under the sound processor magnet to ensure good sound transmission and reduce the risk of soft tissue complications.
A global multicentre clinical investigation concluded that the Baha Attract System was safe and effective. Importantly,
speech understanding in noise tests demonstrated significantly improved results over the pre-operative Baha Softband
scores. To ensure clinical effectiveness, Cochlear followed the first 203 surgeries and fittings post commercial launch.
The outcomes were consistent with the pre-clinical and clinical investigation, demonstrating that the Baha Attract System
delivers excellent hearing outcomes and straightforward surgery.
INTRODUCTION

For people with conductive hearing loss, mixed hearing loss or single-sided
sensorineural deafness (SSD) bone conduction hearing implants (e.g. the
Baha System) provide an excellent method for rehabilitation of hearing
loss1. The elegance of the system relies on the ability to transmit sound
directly to the cochlea by bone conduction. For many years, the principal
method was to anchor the system on an osseointegrated titanium implant
with a percutaneous abutment connecting directly to a sound processor.
This configuration serves as an optimum method of sound transfer;
however, there was still a clinical need for a non skin penetrating solution.
The Baha Attract System was developed to answer this need.
The Baha Attract System is a magnetic bone conduction hearing system
intended to provide hearing to patients with conductive hearing loss, mixed
hearing loss or single-sided sensorineural deafness, without the need for a
skin penetrating abutment. The Baha Attract System includes an internal
magnet (BIM400 Implant Magnet), which attaches to the BI300 Implant
by means of a fixation screw (Figure 1). The implanted parts are completely
underneath the skin and are inserted in a straightforward surgical procedure,
which in most aspects is identical to traditional Baha surgery (e.g. with a
Baha Connect System). Bone polishing may be required, in case of an uneven
bone surface, to accommodate the implant magnet. The system is designed
for soft tissue thickness of 3 mm to 6 mm; tissue thinning is required if the
thickness exceeds 6 mm. The sound processor is held in place by means
of a sound processor magnet (SP Magnet). The SP Magnet features a Baha
SoftWear Pad on the tissue facing surface, which adapts to the underlying
surface and evenly distributes the pressure on the skin.
Importantly, both the Baha Connect System and Baha Attract System
share the same BI300 Implant. This implant features a moderately rough
surface, TiOblast™, and has been shown in a number of studies with long-
term follow-up to have superior stability and faster osseointegration than
previous generation, machined-surface Brånemark implants.2-4 This enables
the transition between the systems if hearing or lifestyle needs change. In
terms of hearing performance, both systems are compatible with the same
sound processors. Therefore, patients can take advantage of the advanced
signal processing and wireless capabilities available in the latest Baha
sound processors. The Baha Fitting Software is designed to automatically
compensate for skin attenuation by increasing the available amplifications
when selecting the Baha Attract System.
* The Cochlear™ Baha® 4 Attract System consists of: Cochlear™ Baha® BI300 Implant,
Cochlear™ Baha® BIM400 Implant Magnet, Cochlear™ Baha® SP Magnet, Cochlear™
Baha® Sound Processor. **SP Magnet soft pad.
To evaluate the performance of the Baha Attract System we took three
approaches. First, we performed technical investigations of the various
components of the system. These have been previously described5 and will
be briefly summarised here. Second, we undertook a global multi-centre
clinical investigation focusing on the hearing performance and safety of
the system6. Third, we followed the first 203 surgeries of the commercially
available system to ensure that the clinical experiences match the design
specifications7.
BIM400 Implant Magnet
SP Magnet
Baha sound processor
BI300 Implant
Figure 1. Cochlear Baha 4 Attract System comprising the BI300 Implant, BIM400 Implant
Magnet, sound processor magnet and Baha sound processor. Six different strengths of SP
Magnets are available to suit different flap thicknesses and patient lifestyles.
TECHNICAL INVESTIGATIONS
As part of the development of the Baha Attract System we conducted
a number of key investigations. Although these have been summarised
previously5 we would like to draw attention to two conclusions in particular.
First, an investigation into the transmission efficiency of the system.
Second, a methodology to improve the contact area of the magnet
connection system.
Transmission efficiency is a key question in the development of magnetic
connection systems. We know that attenuation of sound will occur
as sound travels through the soft tissue.8,9 The key to the successful
development of the system was to determine a method to minimise the
transmission loss. Figure 2 summarises a key comparison between the
Baha Connect System, Baha Attract System and performance with a Baha
Softband. The Baha Connect System serves as the “gold standard” in terms
of transmission.
Similar to previous studies, we observe the attenuation of sound when
comparing the Baha Softband and the Baha Connect System. Due to the
implanted magnet on the BI300 Implant, the degree of attenuation is
reduced when compared to the Baha Softband. The clinical implication of
this finding of improved transmission with the Baha Attract System is that
patients should perform at least as good or better post-operatively with
the Baha Attract System than the pre-operative evaluation on the Baha
Softband. Therefore, patient testing on the Baha Softband provides a good
predicton of post surgical hearing outcomes.

This finding was confirmed by a recent study8 which used a purpose built
adaptor to attach the Baha Attract System to the abutment of existing
patients. The key finding was that while there was attenuation of sound
through the soft tissue, the sound processor could be fitted in such a way
to increase the amplification and thereby reduce the impact on audibility
or speech recognition measures, providing hearing performance that was
superior to the testband.
Figure 2. Comparison of sound transmission through the Baha Connect System (orange),
Baha 4 Attract System (blue) and Baha Softband (grey).
In previous magnetic connection systems, compression of the soft tissue
and effective sound transfer has been a key challenge. The new finding was
that, unlike the Baha Softband, increasing the retention force, by increasing A
the magnet strength for instance, did not provide an improvement in
hearing performance.8 Therefore, the key technological focus was to ensure
the greatest possible surface area in contact with the soft tissue and that
the pressure was uniform. Utilising a highly sensitive pressure measuring
tool (i-Scan®: Tekscan, Boston, MA, USA), we determined, that given the
inconsistent shape of the skull and soft tissue, a rigid magnetic plate

Increase in peak pressure

would have areas of variable pressure and also incomplete surface contact.
This finding raised concerns due to the need to increase the contact force
to ensure a sufficient surface area for sound transmission. Similarly, an
increase in force may create areas of high pressure leading to soreness. The B
solution for this challenge was the use of bio-compatible pressure sensitive
memory foam. As shown in Figure 3, the use of the Baha SoftWear Pad,
with the same magnetic force, will provide a more equal distribution of
pressure across the magnet. This has two key advantages. First, it reduces
the pressure against the skin, thereby reducing the probability of soft tissue
complications. Second, it increases the surface area of contact between the
SP Magnet and the skin leading to improved sound transfer. Figure 3. Comparison of i-Scan pressure measurements taken without (A) and with
(B) the Baha SoftWear Pad, demonstrating that a significantly greater surface area is in
The Baha Attract System was based on the BI300 Implant to enable contact with the skin and peak pressure is lower when the Baha SoftWear Pad is used.
efficient transfer of sound through a single-point transmission system.
In addition, to ensure that sufficient retention force could be used while
avoiding soft tissue complications, we utilised a unique Baha SoftWear n=27
15

IMPROVEMENT
Pad to provide efficient distribution of pressure, thereby maximising sound p<0.0001

transmission.
10
MULTICENTRE CLINICAL INVESTIGATION
Speech to noise ratio (SNR)

10.1

Prior to the regulatory approval of the Baha Attract System, we conducted 5

a multicentre clinical investigation focusing on hearing performance and
p=0.009
clinical safety6. A Cochlear-sponsored clinical investigation was initiated
in four research hospitals in four countries: The HEARing Cooperative 0

Research Centre (Melbourne, Australia), The Chinese University of Hong

-1.1
Kong (Hong Kong, China), Bnai Zion Hospital (Haifa, Israel) and Clínica Las
Condes (Santiago, Chile). The study included 27 adult patients, 17 patients -5

with conductive/mixed hearing loss and 10 patients with SSD. Surgery -4.9

and healing was uneventful in all patients. Sound processor loading was
-10
performed four weeks after implantation. Patients were able to select
Unaided Baha Softband Baha Attract System
either of the commercially available sound processors at the time. Six
patients used the Cochlear Baha BP100 Sound Processor and 21 patients Figure 4. Comparison of the speech recognition in noise scores (50% correct) of
used the Cochlear Baha BP110 Sound Processor. All patients have now pre-operative unaidedin
Adaptive speech and Baha Speech
noise. Softbandto
configurations
noise ratiowith the understanding).
(50% Baha Attract System
reached the final evaluation time point of the investigation, nine months at nine months post-operative.
Baha Attract (at 9 months) compared to Unaided and Softband (at baseline). All sites.
after implantation. The research focused on the hearing performance and
safety of the system.
Has the scar been painful in the past few weeks?
Audiological outcomes with the Baha Attract System were compared with Any neuropathic pain during the past weeks?
unaided hearing and pre-operative tests using the same sound processor on
a Baha Softband. The Baha Attract System provided a statistically significant 1 2 3 4 5 6 7 8 9 10
improvement in word recognition in quiet compared to unaided hearing and No, not at all Yes, very much
similar to the performance with the sound processor on a Baha Softband.
Figure 5. Scores on the pain scale between 1-10 for the conditions of neuropathic pain
and pain around the scar.
 90
In adaptive speech tests in noise, which represents the most difficult
listening situation, the patients performed significantly better with 80

the Baha Attract System, both compared to the unaided situation and 70
compared to the Baha Softband situation (Figure 4).

Number of patients
60

50
Low levels of reported pain (Figure 5) and limited soft tissue complications
(only two cases of mild redness) suggests good wearing comfort with the 40
system. Evaluation of the pressure between the SP Magnet and skin surface 30
showed that the mean pressure (0.14 N/cm2) remained well below the
capillary blood pressure (~0.4 N/cm2), which is of importance to maintain 20

a healthy soft tissue. Analysis of the pressure distribution showed that 10

the SoftWear™ Pad effectively distributes the pressure across the contact 0
surface, without formation of areas with high peak pressure (Figure 3). After <10 11-20 21-40 41-60 >60
initial fitting, fourteen of the patients changed to a weaker SP Magnet, most Age (N=203)
likely to accommodate for a gradual compression/adaptation of the soft
Figure 6. Distribution of patient age.
tissue. Two patients changed to stronger magnets.

In summary, this multicentre clinical investigation concluded that the Baha

Attract system demonstrated good clinical performance in terms of hearing Sound Processor Magnet No of participants Percentage
selected
performance and safety. Importantly, the patients performed as good as
or better than their per-operative performance with the softband and that SPM 5 65 40%
hearing performance continued to improve over time as they became
adapted to the system. SPM 4 47 29%

SPM 3 40 25%
POST MARKET FOLLOW UP
SPM 2 9 5%
A global post-market follow-up focused on the first experiences with the
Baha Attract System7. At surgery and fitting, the healthcare professional was SPM 1 2 1%
provided with a one page questionnaire to capture the key outcomes. Any
additional issues were captured via a separate “event” questionnaire. The Table 1. Sound Processor Magnet selected (% of total number of participants).
purpose was to gather information regarding the surgical outcomes and the
hearing performance at fitting.
n=163
Questionnaires were gathered from the first 203 surgeries and 163 fittings 97%
(80% response rate). Both adult and paediatric patients participated
(Figure 6) with either conductive hearing loss (55%), mixed hearing loss
(13%) or SSD (32%). Interestingly, 33% of respondents reported that they
had previously said no to a system with an abutment. Therefore, the Baha
Attract System complements the Baha Connect System by providing an 0% 20% 40% 60% 80% 100%
additional system configuration to choose from. Similarly, 27% of patients
were under the age of 20, indicating the suitability and application of this 1 (very poor) 2 3 4 5 (very good)
hearing option for paediatric patients.
Figure 7. Speech understanding (intelligibility) as rated on a 5 point scale with 1
Surgeons reported that in most cases the surgery was straightforward being “very poor” and 5 being “very good”.
with an average surgery time of 40 minutes (range: 10-96 minutes).
Increased surgical time was reported to occur for the 25% of patients who n=163
required soft tissue thinning due to the tissue being >6mm and/or the 29% 98%
requiring bone polishing.

In terms of sound processor selection, fitting data was collected from 163 of
the 203 patients (80.2%). Fifty-five point eight percent of patients selected
a Baha BP100 or Baha 4 sound processor and 44.2% selected a Baha BP110
0% 20% 40% 60% 80% 100%
power sound processor. The selection choice for the sound processor was
in most cases driven by the hearing loss, where the majority of patients 1 (very poor) 2 3 4 5 (very good)
with conductive hearing loss or SSD chose a Baha BP100 or Baha 4 sound
processor, while the majority of patients with mixed hearing loss chose the Figure 8. Sound quality as rated on a 5 point scale with 1 being “very
power option. poor” and 5 being “very good”.

Therefore, the degree of cochlea damage combined with the effects of n=163
soft tissue attenuation, and transcranial attenuation in the case of SSD 81%
patients, was key to sound processor selection. In terms of SP Magnets, all
patients had good retention with the selected magnet (Table 1). Shortly
after the post-market follow-up an additional sixth magnet was available
to give an additional stronger option to those who were wearing the SP
Magnet 5. Magnet selection was principally related to soft tissue thickness 0% 20% 40% 60% 80% 100%
and lifestyle choice with paediatric patients typically receiving a weaker
magnet compared with adults. Importantly, very few patients reported Much too soft Too soft Ideal
issues related to uncomfortable pressure, which was resolved by selecting a
Too strong Much too strong
weaker magnet at follow-up.
Figure 9. Loudness as rated on a 5 point scale with 1 being “much too soft” and 5
being “much too strong”.
In terms of hearing performance, three questions were asked focusing on speech
intelligibility (Figure 7), sound quality (Figure 8) and loudness (Figure 9). The
results of the fittings were excellent, in that >97% of patients stated that the
speech understanding and sound quality were acceptable or better. In terms of
loudness, 81% stated the loudness was ideal with the remainder saying it was
either too loud or too soft. It should be remembered that this was the results
of the initial fitting and one would expect even better performance after
some time for adaptation and/or fine tuning. The results were consistent with
the multicentre clinical study in demonstrating the clinical utility of a bone
conduction hearing implant using a magnetic connection.
CONCLUSIONS
The Baha Attract System is the result of a systematic innovation process
from careful technical development through to a comprehensive
multicentre clinical investigation and monitoring of the first 203 surgeries
and 163 fittings performed globally post launch. The results are consistent.
The Baha Attract System is an effective bone conduction hearing solution
for people with conductive hearing loss, mixed hearing loss or SSD.
Overcoming the challenges of soft tissue attenuation was achieved through
the use of a single-point sound transmission and distribution of pressure
through the Baha SoftWear Pad combined with the wider portfolio of
sound processors. The absence of a skin-penetrating abutment provides
cosmetic and medical advantages. Importantly, the need for daily cleaning
of the abutment site is eliminated, as well as the local soft tissue reactions
associated with an abutment.
REFERENCES
1. Snik AF, Mylanus EA, Proops DW, et al. Consensus statements on the
BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol
2005;195:2-12.
2. Sennerby L, Gottlow J, Rosengren A, Flynn M. An experimental evaluation
of a new craniofacial implant using the rabbit tibia model: Part II.
Biomechanical findings. Otol Neurotol 2010;31:840-5.
3. Gottlow J, Sennerby L, Rosengren A, Flynn M. An experimental evaluation
of a new craniofacial implant using the rabbit tibia model: part I.
Histologic findings. Otol Neurotol 2010;31:832-9.
4. Dun CA, de Wolf MJ, Hol MK, et al. Stability, survival, and tolerability of
a novel baha implant system: six-month data from a multicenter clinical
investigation. Otol Neurotol 2011;32:1001-7.
5. Flynn M. Design concept and technological considerations for the
Cochlear Baha 4 Attract System. Mölnlycke, Sweden: Cochlear Bone
Anchored Solutions AB; 2013.
6. Smeds H, Van Hasselt A, Luntz M, et al. Clinical outcomes from an
international multi-center clinical investigation of a new magnetic bone
conduction implant system. In: 13th International Conference on Cochlear
Implants and Other Implantable Auditory Technologies. Munich; 2014.

Comparisons with Baha Softband tests showed similar or better outcomes
with the Baha Attract System; notably, the improvement in speech
recognition in noise with the Baha Attract System was statistically
significant. The results suggest that tests with the sound processor on a
Baha Softband will be a useful tool in the counselling of patients that are
candidates for a Baha Attract System, as it gives a good indication of the
patient’s post-operative hearing outcome.
The clinical investigation and the post launch follow-up showed that the
Baha Attract System provides good hearing performance with good wearing
comfort and minimal pressure-related soft tissue complications.
7. Sandberg, A., Wigren, S. & Flynn, M. Global clinical outcomes of a
magnetic retention bone conduction hearing system. 13th International
Conference on Cochlear Implants and Other Implantable Auditory
Technologies, Munich, 18-21 June 2014.
8. Verstraeten N, Zarowski AJ, Somers T, Riff D, Offeciers EF. Comparison
of the audiologic results obtained with the bone-anchored hearing aid
attached to the headband, the testband, and to the “snap” abutment.
Otol Neurotol 2009;30:70-5.
9. Kurz A, Flynn M, Caversaccio M, Kompis M. Speech understanding with
a new implant technology: A comparative study with a new non-skin
penetrating Baha® system. BioMed International in press.

Manufacturer:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden
Tel: +46 31 792 44 00 Fax: +46 31 792 46 95

Regional offices:
Cochlear Ltd (ABN 96 002 618 073) 1 University Avenue, Macquarie University, NSW 2109,
Australia Tel: +61 2 9428 6555 Fax: +61 2 9428 6352
Cochlear Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA
Tel: +1 303 790 9010 Fax: +1 303 792 9025
Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland
Tel: +41 61 205 0404 Fax: +41 61 205 0405

www.cochlear.com
Ardium, Baha, Baha Divino, Baha Intenso, Baha PureSound, Baha SoftWear, DermaLock, Vistafix and
WindShield are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB.
Cochlear, Hear now. And always and the elliptical logo are either trademarks or registered trademarks
of Cochlear Limited. The TiOblast™ surface technology is licensed from Astra Tech and TiOblast™ is
a trademark of Astra Tech. © Cochlear Bone Anchored Solutions AB 2014. All rights reserved. JUN14.
Printed in Sweden.
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