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