the us electrical acoustic stimulation (eas) clinical trial ...€¦ · • duet speech processor...
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The US Electrical Acoustic Stimulation (EAS) clinical trial: Audiological results
ACIA Washington, D.C. October 16, 2015
Diane Martinez, AuD Sandra Velandia, AuD Annelle Hodges, PhD Sandra Prentiss, PhD
Fred Telischi, MD Adrien Eshraghi, MD
Purpose • To assess residual hearing and speech perception of
patients using the MED EL DUET processor and Flex EAS implant
• Multicenter study
Participating sites • Boys Town National Research Hospital, Omaha, NE • Duke University Medical Center, Durham, NC • Hospital of the University of Pennsylvania, Philadelphia, PA • Indiana University School of Medicine, Indianapolis, IN • Medical College of Wisconsin, Milwaukee, WI • New York Eye & Ear Infirmary, New York, NY • Oregon Health Sciences University, Portland, OR • Stanford University, Stanford, CA • Swedish Neurosciences, Seattle, WA • University of Kansas Medical Center, Kansas City, KS • University of Miami Ear Institute, Miami, FL • University of Michigan, Ann Arbor, MI • University of North Carolina Hospitals, Chapel Hill, NC • University of Texas SW Medical Center, Dallas, TX
Candidacy Criteria
CAUTION: Investigational device. Limited by US law to investigational use.
Background • DUET speech processor for
electric-acoustic stimulation (EAS) • DUET external system is used in
conjunction with the Sonata receiver stimulator together with the FLEX electrode design.
• Longer than other hearing preservation electrodes
CAUTION: Investigational device. Limited by US law to investigational use.
Reported Results with DUET
A. Adunka, O., Dillon, M., Adunka, M., King, E., Pillsbury, H., & Buchman, C. (2013). Hearing preservation and speech perception outcomes with electric-acoustic stimulation after 12 months of listening experience. The Laryngoscope, 123, 2509-2515.
B. Helbig, S., Heyning, P., Kiefer, J., Baumann, U., Kleine-Punte, A., Brockmeier, H., . . . Gstoettner, W. (2011). Combined electric acoustic stimulation with the PULSARCI 100 implant system using the FLEX EAS electrode array. Acta Otolaryngol Acta Oto- laryngologica, 131, 585-595.
B
CAUTION: Investigational device. Limited by US law to investigational use.
Background: Sentences in noise
0
20
40
60
80
100
pre-op HA CI FF EAS
% c
orre
ct (m
ean)
Pre-op HA
HA-only CI-only EAS
1st fitting 3 months 6 months 12 months
A. Adunka, O., Dillon, M., Adunka, M., King, E., Pillsbury, H., & Buchman, C. (2013). Hearing preservation and speech perception outcomes with electric-acoustic stimulation after 12 months of listening experience. The Laryngoscope, 123, 2509-2515.
B. Helbig, S., Heyning, P., Kiefer, J., Baumann, U., Kleine-Punte, A., Brockmeier, H., . . . Gstoettner, W. (2011). Combined electric acoustic stimulation with the PULSARCI 100 implant system using the FLEX EAS electrode array. Acta Otolaryngol Acta Oto-laryngologica, 131, 585-595.
A. B.
CAUTION: Investigational device. Limited by US law to investigational use.
Subjects Patient Gender Ear
implanted Electrode Duration of
deafness (yrs)
Etiology
Age at implantation
1 F Right FLEX EAS 13 Noise induced
65
2 F Left FLEX EAS 16 Unknown
52
3 F Right FLEX EAS 17 Viral 67
Procedures • Speech perception was evaluated at the following visits:
– Pre op (baseline), initial stimulation, 3, 6 and 12 months post initial stimulation
• CNC words and CUNY sentences tested in the following conditions: -CI only -HA only -EAS
CAUTION: Investigational device. Limited by US law to investigational use.
Results: Change in hearing
Cha
nge
in h
earin
g (d
B)
Frequency (Hz)
Results: Hearing preservation Pt 1 Pt 2
Frequency (Hz) Frequency (Hz)
Inte
nsity
(dB
)
Inte
nsity
(dB
)
Results: Hearing preservation Pt 3
Inte
nsity
(dB
)
Frequency (Hz)
Results
0
10
20
30
40
50
60
70
80
pre-op 3m 6m 12m
Sco
re (%
Cor
rect
)
CNC words
HA
CI
EAS
CAUTION: Investigational device. Limited by US law to investigational use.
Results
%
0 10 20 30 40 50 60 70 80 90
100
pre-op 3m 6m 12m
Sco
re (%
Cor
rect
)
CUNY Sentences at +5dB SNR
HA
CI
EAS
CAUTION: Investigational device. Limited by US law to investigational use.
Discussion: Programming
Hodges, A., Balkany, T., Ruth, R., Lambert, P., Dolanash, S., & Schloffman, J. (1997). Electrical middle ear muscle reflex: Use in cochlear implant programming. Otolaryngology - Head and Neck Surgery, 117(3), 255-261.
Conclusions • Despite initial loss at surgery, hearing thresholds are
maintained. • Even with longer array, there is stability in hearing levels. • In noise conditions, EAS tends to yield better results
than a traditional hearing aid.
CAUTION: Investigational device. Limited by US law to investigational use.
Considerations and Directions • ESRTs can be a valuable tool for use in programming CI
patients, including EAS patients • Consider the FLEX electrode arrays when hearing
conservation is the aim • The use of a longer array with complete cochlear
coverage (ccc) still results in good hearing preservation and gives advantage of adequate electrical stimulation without the need of re-implantation.
CAUTION: Investigational device. Limited by US law to investigational use.
Discussion • Evidence that
electrode length is not correlated to hearing loss
Prentiss, S., Sykes, K., & Staecker, H. (2010). Partial Deafness Cochlear Implantation at the University of Kansas: Techniques and Outcomes. J Am Acad Audiol Journal of the American Academy of Audiology, 21, 197-203.
CAUTION: Investigational device. Limited by US law to investigational use.
Thank you for your attention