Effects of Setting Thresholds for the MED- EL Cochlear Implant System in Children

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Effects of Setting Thresholds for the MED- EL Cochlear Implant System in Children Stacy Payne, MA, CCC-A Drew Horlbeck, MD Cochlear Implant Program 1

Background Movement in CI programming is to shorten appointment times and streamline fittings Reduction in reimbursement RVU demand at clinics causing shortening of appointment times Expansion of CI services to new clinics Most adults are physically and mentally capable of setting thresholds Children, however, may not have the readiness skills for or have learned the conditioned play task With children, additional concerns include attention, fatigue and the global assumption that they are not able to accurately set thresholds 2

Background Manufacturers are suggesting to focus on upper stimulation levels Significant research has been done on the setting of upper stimulation levels Behavioral settings and balancing Objective measures like esrts and ECAPs For at least 2 devices, it has been suggested by manufacturer representatives to set thresholds to 0 or to 10% of the MCL This would alleviate the need to set thresholds and allow for shorter programming session appointments while increasing profitability 3

Previous research Skinner et al (1999) evaluated 2 methods for setting thresholds with Cochlear s N22 device Counted thresholds were found to be most effective Uses different processing, bipolar stimulation and smaller input DR Spahr and Dorman (2005) evaluated thresholds set to 0 or 10% in adults with the MED-EL device (C40+ implant with TEMPO+ processor) No significant differences found for sentences at low levels in quiet or noise or for consonants and vowels for either condition Significant difference on consonant test noted for voicing but not for place or manner of articulation Authors noted that the importance of low level inputs should not be overlooked for sound awareness or incidental learning in pediatric populations 4

Previous Research Boyd (2006) evaluated how thresholds and maplaw effect acoustic thresholds and speech discrimination in adults MED-EL C40+ implant with the clinic s CIS PRO+ body worn processor Set behavioral thresholds and MCL then made 3 maps Behavioral threshold, BT X 2, and minimum Evaluated the effects on acoustic thresholds for how thresholds were set, maplaw, background threshold stimulation ( hum ) and speech discrimination Setting thresholds did not effect the CI audiogram or speech discrimination significantly but did produce audible hum Steeper maplaws produced lower acoustic thresholds 5

Considerations for Children Young implanted children typically: Have little to no language at time of implantation Acoustic demands range from quiet to excessive noise Much of their listening in early years is through overhearing and incidental learning Children need to hear soft sounds Access to sound/speech is critical for a child to learn to listen and speak Children learn to speak how they hear! 6

Flexer and Madell s speech string bean Flexer and Madell Children need to hear in The Speech String Bean The softest part of the speech banana = 15-20dBHL 7

MED-EL s Recommendations Chris Durst at MED-EL UK Ltd (handout provided by ME rep) For the overwhelming majority of pt.s, MCL is the only critical parameter to ensure good performance. (All others can be left at default). For a small subset of patients other parameters such as THR etc. may be important in securing good performance. Clinicians' priority (in general) should be to focus on measuring accurate MCLs THR levels must be INaudible Use a PTA type technique to determine threshold Then adjust downward 1/2/3 steps 8

Current Study Evaluate the use of thresholds following MED-EL s recommended fitting technique versus 10% of MCL on behavioral acoustic thresholds and speech perception in children 13 children aged 5 years to 18 years (mean = 12 years, 6 months) Etiology: n = 1 n = 1 n = 4 n = 7 Genetic CI use ranged from 1y, 8m to 15y, 4m in at least one ear Unknown Mean = 9 years, 11 months Meningitis EVA 9

Current Study 7 subjects were bilateral users and 6 were unilateral 20 total implants Implant 10 8 6 4 2 0 Internal 8 9 5 1 C40+ Pulsar Sonata Concert 10

Current Study All subjects used the OPUS 2 processor Verified good working condition prior to testing No issues or problems with device or hearing prior to testing All subjects used: Maplaw = 1000 FSP (n=12) or FS4 (n=1) Default frequency range for internal 11

Methods Behavioral thresholds were set using a conditioned play technique (n = 2) or behavioral indication I hear it or Yes (n = 11) Once subject heard the stimuli, levels were decreased in 1 down arrow steps until no response was obtained Threshold level where response was obtained was then reduced by 3 down arrow clicks to ensure inaudibility (verified by presenting stimuli for response) 12

Methods MCLs were rechecked using loudness judgments and all were not significantly different than previous MAPs A new map was created with thresholds set at 10% MAPs were downloaded to the recipient s processor and synced to clinic remote Subject had no access to change volume or sensitivity MAPs changed by tester Randomized use of MAPs were used for testing 13

Testing Testing was completed in a calibrated Acoustic Systems soundbooth using a GSI 61 audiometer Subjects were seated 1 meter from speaker at 0 degree azimuth Warble tone stimuli was used for behavioral acoustic threshold measurements at 250, 500, 1000, 2000 and 4000 Hz Speech perception testing was completed using MLV presented at 50dBHL Small subset of subjects tested in noise at +5SNR Tests included CNC words and HINT sentences (2 lists) 14

Results Audiogram results using measured thresholds Hz 250 500 1000 2000 4000 S1 20 15 15 15 20 S2 20 15 15 20 20 S3 15 20 20 15 15 S4 15 10 10 10 15 S5 15 15 20 15 20 S6 15 15 15 15 20 S7 15 20 15 20 15 S8 20 20 20 20 20 S9 20 20 20 20 20 S10 15 20 15 15 20 S11 20 20 20 20 20 S12 20 20 20 20 20 S13 15 15 10 15 15 17.31 17.31 16.54 16.92 18.46 15

Results Audiogram results using 10% of MCL Hz 250 500 1000 2000 4000 S1 30 25 25 25 30 S2 20 20 25 30 35 S3 15 20 25 40 35 S4 30 25 25 25 30 S5 35 30 25 30 35 S6 15 25 25 25 30 S7 25 25 30 30 35 S8 20 25 30 35 40 S9 20 25 30 35 35 S10 25 20 25 30 35 S11 20 25 25 35 40 S12 25 30 25 25 35 S13 25 30 30 35 40 23.46 25.00 26.54 30.77 35.00 16

Results 0 Average acoustic thresholds 250 500 1000 2000 4000 dbhl 10 20 Measured 10% 30 40 p < 0.05 for all frequencies 17

Results Speech Perception in Quiet % Correct 100 90 80 70 60 50 40 30 20 10 0 91.4 Word 76 p=.00000008 97.8 87.8 Sentence Measured 10% 18

Results Speech Perception in Noise (+5 SNR) n = 5 100 80 89.6 97.8 78 68.8 % Correct 60 40 20 Measured 10% 0 Word p=.00016 Sentence p=.0074 19

Results Testing in Noise Data % Correct 100 80 60 40 20 100 100 92 92 72 76 76 71 95 97 96 97 88 91 80 78 72 74 60 64 0 S1 S2 S3 S4 S5 Word-measured Word-10% Sent-measured Sent-10% 20

Conclusions Behavioral thresholds of good reporters and using MED-EL s recommended procedures yielded results at lower audiometric levels Within normal limits (average of 16-18dB) Within the speech string bean range 10% of MCL thresholds in this study yielded poorer behavioral audiograms BWNL to mild hearing loss range (average of 23-35dB) Decreased speech perception scores were noted for both word and sentence tests in quiet with 10% THR In a subset of subjects, word and sentence scores decreased significantly in noise when using 10% THR program 21

Conclusions If children have poorer access in quiet and even worse access in noise, their speech and language development can be severely restricted over time Generalizations of adult data to children should be considered carefully before implementation so as to not inhibit hearing and speech and language progress in developing children Continued research is needed 22