Vanderbilt Bill Wilkerson Center for Otolaryngology

and Communication Disorders

Bone Conduction Implants

Krissie Bratt Rigsby,
Rigsby, Au.D.
Au.D.
Pediatric Audiologist
g
Vanderbilt Bill Wilkerson Center
National Center for Childhood Deafness

Lisa Vaughan-
Vaughan-Christensen,
Christensen Au.D
Au
Au.D.
D.
Pediatric Audiologist
Arkansas Children’s Hospital
 O tli
Outline
• Overview of Bone Conduction
Implants
• History
• Surgery
• Candidacy
• New
N D
Devices
i
• Selection/Verification/Validation
•Disclosure:
Di l I do
d nott have
h any
financial or other relationship
with any vendor or manufacturer
represented in the following
discussion(s)
discussion(s).

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 Hi t
History
• First application of titanium implants in
the temporal bone was in 1977
• Pioneered in Gothenburg Sweden
• Has become a wellwell--established and
successful method of auditory
rehabilitation
h bilit ti
• Initially for conductive and mixed hearing
losses, but now used for single sided
deafness

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 PATHWAYS
for bone conduction
• Ear
E canal:
canall: cartilaginous
til i portion
ti off ear canall resonates,
t
creates sound waves in canal to strike TM
• Most sound leaks out the open EAC

• Middle ear:
ear: as skull moves with sound vibrations, the bony
chain swings/sways and causes vibrations to the inner ear
(similar to air conduction hearing aid)

• Inner ear:
ear: bones of the skull are compressed; this
movement causes changesg in size and shape
p of cochlea
which creates fluid
f movement and triggers response

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 Composite BC Stimulation

OUTER, MIDDLE, & INNER

ear stimulation

Hearing
g response
p of the inner ear
is a direct result of all three
stimulation p
pathways y

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Term “osseointegration
“osseointegration”:
”: os meaning
“bone” and integro meaning “renew”;
th process by
the b which
hi h living
li i bone
b
tissue bonds with titanium

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Surgical and Healing Process
• Outpatient surgery, relatively non-
non-invasive

• Surgically placed implant is connected to an abutment that will protrude

through the skin

• Small, hair
hair--free, possibly numb area will remain around the abutment

• Dressing and pressure bandage for one to two weeks following surgery

• 3 months for osseointegration before external sound processor is fit for

adults

• Procedure for Very Young Children - Two Stage Operation: The first stage
involves drilling holes for the fixture and placing a sleeper receptor under
the skin and allowing the skull to continue to thicken. After
osseointegration (can be 6 6--8 months) the "post"
post is attached during a
second surgery

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Ab t
Abutment
t

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P
Processor
rocessor

•External sound
processor which
connects to the implant
via an abutment

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S ftb d
Softband

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 N
New D
Devices
i
1) BP 100
100--Cochlear Corp

2)) Ponto
Ponto--Oticon Medical

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 I t d i
Introducing….Oticon
Introducing….Oti
Oticon P t
Ponto
• Why Oticon Medical?
• The most up to date product...
• Oticon RISE platform, Superb design
• Intuitive and flexible fitting
fitting, Innovative improvements
• From a solid company...
• 100 years of experience in traditional hearing aids
• Based on and committed to a scientific approach
pp to
R&D
• Great people and service organization
• Developed and supported by a dedicated and experienced
team of experts…
experts

Co rtes of Oticon Medical

Courtesy

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 Design
Design is not just how it looks 
is not just how it looks – it is 
it is
how it works

• Advanced processing
• Easy to use
• Easy to configure

Courtesy of Oticon Medical

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Design is not just how it looks – it
is how it works
Advanced features for new technology
Big and easy to find/use program button

Automatic selection of best user features

Self learning volume control

Battery warning system

•

Courtesy
y of Oticon Medical

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Design is not just how it looks – it
is how it works
Easy to configure
Can be adapted to any user need
Special programs for special needs
Can turn off…
Volume control
Directionality
Noise reduction

Courtesy of Oticon Medical

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Design is not just how it looks – it
is how it works

Courtesy of Oticon Medical

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 •courtesy of Cochlear Corp

2009 Baha p
portfolio

•Cochlear Baha® BP100 •Baha Intenso™ •Baha® Cordelle II

•C
Client
e t need:
eed •Client need:
•Top performance, fully •Client need: •Super power, body-
body-
automatic, head-
head-worn, •Head
Head--worn power, worn
•All
All--round device •Discreet device

•CAM MKTP-
MKTP-170 Vanderbilt Bill Wilkerson Center
 •courtesy of Cochlear Corp

•Brilliance in design
• Modern design for greater cosmetic appeal

• Easy FM/phone integration with Europin

• U off skin-
Use skin
ki -friendly
f i dl titanium
tit i platform
l tf

• Symmetrical device – use BP100 on left or right

side, inventories are reduced

• Status indication with beeps and LEDs

• Tactile button user interface for ergonomic

operation reducing the risk for accidental
program changes
•CAM MKTP-
MKTP-170 Vanderbilt Bill Wilkerson Center
•courtesy of Cochlear Corp
Simplicity in use - flexibility in
fitting

•Button •3 •Cochlear Baha Fitting

•1 •Ready to wear •2 programming Software

Time

Individulization

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•Designed for kids

Visual and audible Keylock secures The optional

indicators provide the ergonomic tamper--proof door
tamper
sound processor buttons from keeps the battery
status and low accidental changes from being
battery warning removed

•courtesyy of Cochlear Corp

p

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•Designed for kids

Safety line secures The standard Baha Softband

BP100 to the child’s Europin connector compatibility for
clothing to prevent allows easy infants and
it from being lost integration with toddlers
classroom FM
systems •courtesy of Cochlear Corp

•CAM MKTP-
MKTP-170 Vanderbilt Bill Wilkerson Center
 FDA Clearance
1996 - The Baha System was cleared to treat mixed and
conductive hearing loss.

1999 - The Baha System was cleared for pediatric use in children
age five and older.

2001 - The Baha System was cleared for bilateral fittings. In 2002,
the Baha®
Baha® Softband was introduced for children under the
age of five.

2002 - The Baha System was cleared for use in patients with
unilateral sensorineural hearing loss also known as single
sided deafness™
deafness™ (SSD).

2009 - Oticon Ponto and Cochlear BP100 cleared as programmable

devices

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 Candidacy
• Conductive/ mixed hearing loss
• 5 years of age and older
• BC PTA for BP100 45 dBHL (at .5,5 11, 2
2, 3 kHz)
• BC PTA for Intenso 55
55--60 dBHL
• 60
60%% or better monosyllabic word score

• Single Sided Deafness (SSD)

• Transcranial routing from the deaf side to the WNL ear
• 5 years of age or older
• profound
f d SNHL and d normall h
hearing
i iin th
the opposite
it ear
• 20 dBHL AC PTA (.5k, 1k, 2k, 3kHz
3kHz))

• Asymmetrical hearing losses? (profound one ear,

ear SNHL in
contralateral ear)

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Audiologic Assessment
Pre--operative
Pre
PEDIATRICS
• Puretone & speech
audiometry

• Speech in noise testing

• Soundfield NuCHIPS,
NuCHIPS,
PBK, WIPI

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 Audiologic Assessment
Pre--operative
Pre
• Use a Baha with a higher force output during
testing (for example: patient is a candidate for BP
100, use the Intenso for the workup)
• Significant difference in headband vs. implant of
5-20 dB in the frequency range of 1000
1000--4000Hz.
• Improvement in SRT of 4 4--7dB which can translate
to 20-
20-40% difference
diff iin speechh understanding
d di

(Versraeten et al. 2008)

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Audiologic Assessment
Pre
re-- and post-
post-operative
PEDIATRIC
• Outcome inventory
measurements
• Children’s Home
Inventory fro Listening
Difficulties (CHILD)
• Children’s Outcome
W k h t (COW)
Worksheets
• Screening Instrument for
Targeting Educational
Needs (SIFTER)
• Infant
Infant--Toddler Meaningful
Auditory Integration Scale
(IT--MAIS)
(IT

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 Verification

• Aided testing in the soundfield

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 V lid ti
Validation
• Outcome measures
• Speech pathologist
• Teachers
• Parents
• Aided Thresholds

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 Evidence--based practice:
Evidence

• Baha > BCHA

• Snik et al ((1995),
) Tjellstron
j ((1995),
) Skik et al ((2004))
• Baha < = > ACHA
• Mylanus et al (1994), Snik et al (1994), Mylanus (1995), Snik
et al (2004)

• Limited studies with random discourse in reverberant,

multi--source noise conditions ((i.e. real world situations))
multi
• Limited studies using pediatric patients

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Newman CW, Sandridge SA, Wodzisz LM. (2008). Longitudinal
B
Benefit
fit F
From and
dSSatisfaction
ti f ti With the
th Baha
B h System
S t for
f
Patients With Acquired Unilateral Sensorineural Hearing Loss.
Otology & Neurotology;
Neurotology; 29:1123-
29:1123-1131.

• Objective: To analyze the short-

short-, medium-
medium-, and long-
long-term benefits from and satisfaction
with the Baha for patients with profound unilateral SNHL.

• Outcome measures used: Speech Perception in Noise, HINT, localization testing, APHAB,
HHIA, and SSD questionnaire.

• Conclusion: The Baha is effective at reducing psychosocial consequences of unilateral

profound SNHL for the long
long--term.

• Improvement in speech understanding occurred when the primary signal was spatially
separated from BGN.

• Localization performance did not improve with Baha use.

• Overall, patients were satisfied with their Baha and would still elect to have this procedure
if given a second chance.

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Christensen L,, Dornhoffer,, JL. (2008).
( ) Bone-
Bone-Anchored Hearing
g
Aids for Unilateral Hearing Loss in Teenagers. Otology &
Neurotolgy;; 29: 1120-
Neurotolgy 1120-1122

• Objective: to report on follow-

follow-up of a case series of teenage
patients who received Bahas to compensate for SSD.

• Results: There were higher CHILD scores post-

post-implant,
implant indicating
improved child and parent satisfaction. Better results on HINT post-
post-
implant indicated an improved ability to understand speech in noise.

• Conclusion: The Baha appeared to be of benefit to these teenage

patients with unilateral hearing loss.

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Christensen L, Richter, G., Dornhoffer, JL. (2010). Update on
Bone--Anchored Hearing Aids in Pediatric Patients With
Bone
Profound Unilateral Sensorineural Hearing Loss. Arch
Otolaryngol Head Neck Surg. 2010;136(2):175-
2010;136(2):175-177.

• Objective:
Obj ti T evaluate
To l t the
th use off bone-anchored
b h dh hearing
i aids
id
(Bahas) in children with single-sided deafness.
• Results: Preimplant mean HINT scores at speech-noise ratios
of 0, +5,
5, and +10
10 dB were 42%, 76%, and 95%, respectively.
Postimplant mean HINT scores improved to mean speech-noise
ratios of 82%, 97%, and 99% at 0, 5, and 10 dB, respectively.
The CHILD scores also improved from mean preimplant ratings
of 4.49 and 4.60 for patients and parents, respectively, to
postimplant ratings of 6
6.90
90 and 7
7.10.
10 Both teenagers (n = 15)
and children younger than 13 years (n = 7) demonstrated
improved HINT and CHILD scores. The complication rate was
17%.
• Conclusions: Bone-anchored
Bone anchored hearing aids are a durable
treatment option that can achieve noticeable improvements in
hearing in noise and in listening difficulties in children with
profound unilateral sensorineural hearing loss.

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Hol MK, Cremers CW, Coppens-Schellenkens W, Snik AF. The
BAHA Softband:
S ftb d A new treatment
t t t for
f young children
hild with
ith bilateral
bil t l
congenital aural atresia. Int J of Ped Otorhinolaryng. 2005;69:973-
980.
• Objectives:To
Obj ti T evaluate
l t the
th validity
lidit off a b
bone-anchored
h dh hearing
i aid
id
(BAHA) Softband (fitted unilaterally and bilaterally) in young children
with bilateral congenital aural atresia.
• Results: The electro-acoustic measurements showed minor differences
in gain between the three devices
devices. At a reduced volume setting
setting, the
mean input level at which the output levelled off was largely
comparable between the BAHA Classic and the conventional device,
but somewhat poorer with the BAHA Compact. Both children showed
speech and language development that was in accordance with their
cognitive development.
• Conclusions: The BAHA Softband was a valid intervention in children
with congenital bilateral aural atresia who were too young for
percutaneous BAHA application
• N=2

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 Christensen, et al (2007) “Aided Verification of Baha
Softbands for Children” Poster Submission
American Academy of Audiology.
• Objective: The purpose of this study was to (a) determine
benefit of Baha coupled to the Softband for infants and children
with bilateral conductive hearing loss; and (b) verify audibility of
the speech spectrum for octave frequencies 500 through 4000
Hz.
• Results: Results revealed an improvement
p in soundfield
thresholds
th h ld with
ith B
Baha
h amplification
lifi ti forf the
th ffour octave
t
frequencies.
• Conclusions: Benefit of the Baha in providing audibility of the
speech spectrum for infants and children with bilateral
congenital conductive hearing loss has been demonstrated.
• N = 20
• Nicholson N, Christensen L, Dornhoffer J, Martin P, Smith-Olinde L.
(2010) Verification of Speech Spectrum Audibility for Pediatric Baha
(2010).
Softband Users with Craniofacial Anomalies. The Cleft Palate-
Craniofacial Journal In-Press.

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S ftb d Case
Softband C
• Failed
F il d NBHS

• Pierre Robin
Sequence

• ABR at 3 months 8
days of age confirmed
moderate CHL AU

• Fit with loaner Baha at

3 months 20 days of
age

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S ftb d Case
Softband C

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 I l t Case
Implant C
• Previously worn BTEs for bilateral
moderate CHL
• Normal pinnas AU
• Chronic otitis externa
• Recommended Baha trial 3-14-2005
• First Stage Baha surgery 8-24-2005
• Second Stage Baha surgery 2-27-2006
• I l t d bil
Implanted bilaterally
t ll

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Implant Case

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 I l t Case
Implant C
• Family choice
• Aided threshold were similar
• Never wore a Softband
• Chronic otitis externa was their
priority
• Still uses FM with Divino as she
did with the BTEs

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 SSD C
Case
• 14 y/o
/ ffemale
l
• Normal hearingg
right
i ht ear
• Profound loss left
ear
• Receives tutoring
g
att school
h l

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SSD C
Case

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 References
• Burrell S.P., Cooper, H.C., Proops
Proops,, D.W. (1996). The bone anchored hearing aid-
aid-The third option for otosclerosis
otosclerosis.. Journal of Laryngology
and Otology Supplement; 21: 31-31-35.

• Christensen L, Dronhoffer,
Dronhoffer, JL. (2008). Bone
Bone--Anchored Hearing Aids for Unilateral Hearing Loss in Teenagers. Otology & Neurotolgy;
Neurotolgy; 29:
1120-1122.
1120-

• Kunst S.J., Myrthe K.S., Mylanus E.A., Leijendeckers,

Leijendeckers, J.M., Snik A.F., Cremers,
Cremers, W.R., (2008). Subjective Benefit After BAHA System
Application in Patients With Congenital Unilateral Conductive Hearing Impairment. Otology and Neurotology;
Neurotology; 29: 353-
353-358.

• Newman CW, Sandridge SA, Wodzisz LM. (2008). Longitudinal Benefit From and Satisfaction With the Baha System for Patients With
Acquired Unilateral Sensorineural Hearing Loss. Otology & Neurotology;
Neurotology; 29:1123-
29:1123-1131.

• Mylanus,
M lan s, E.A.;
Mylanus E A Snik
Snik,, A.F.,
A F Cremers
Cremers,, W.R.
W R (1995)
(1995). Patients’ Opinions of B one Anchored vs.
s Con
Conventional
entional Aids
Aids. Arch Otolar
Otolarrrryngology
Otolarryngology
ngolog
Head and Neck Surgery; 121: 421-
421-425.

• Myrthe K.S., Snik A.F. Mylanus E.A., Cremers W.R. (2005). Long-
Long-term Results of Bone
Bone--Anchored Hearing Aid Recipients Who Had
Previously Used Aif
Aif--Conduction Hearing Aids. Archives Otolaryngology Head Neck Surgery;
Surgery; 131: 321-
321-325.

• Niparko, JK, Cox KM, Lustig LR. (2003). Comparison of the Bone Anchored Hearing Aid Implantable Device with Contralateral Routing of
Niparko,
Offside Signal Amplification in the Rehabilitation of Unilateral Deafness. Otology & Neurotology
Neurotology;; 24: 73-
73-78.

• Snik, A.F., Bosman,

Snik, Bosman, A.J., Mylanus,
Mylanus, E.A., & Cremers,
Cremers, C.W. (2004). Candidacy for the Bone
Bone--Anchored Hearing Aid [Electronic Version].
Audiology & Neuro-
Neuro-Otology
Otology,, 9(4), 190-
190-196.

• Tringali, S., Grayeli,

Tringali, Grayeli, A.B., Bouccara,
Bouccara, D., Sterkers
Sterkers,, O., Chardon, S., Martin, C., et al. (2008). A survey of satisfaction and use among patients
fitted with Baha [Electronic Version]. European Archives of Otorhinolaryngology
Otorhinolaryngology,, 265, 1461-
1461-1464.

• Wazen JJ, et al. (2008). Successes and Complications of the Baha System. Otology & Neruotology
Neruotology;; 29: 1115-
1115-1119.

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