Expanded Indications in the Adult Cochlear Implant Population

Hearing Loss, Sensorineural Clinical Trial

Official title:

Expanded Indications in the Adult Cochlear Implant Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236909
• Other study ID #: G170111
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: March 27, 2023

Study information

• Verified date: August 2023
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Description:

Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .

Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults, 18 years of age or older at the time of implantation

• Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)

• Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB

• Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear

• CNC word score in quiet of greater than or equal to 10% in the ear to be implanted

• Evidence of appropriately fit hearing aids as determined by the audiologist

• Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal

• Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification

• If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study

• Fluent in English

• No radiological contraindications

• Ability to undergo general anesthesia

• Appropriate motivation and expectation levels

• Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

• Evidence that hearing loss is retrocochlear in origin

• Active middle ear infection

• Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction

• History of prior use of a hearing implant

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (18)

Amoodi HA, Mick PT, Shipp DB, Friesen LM, Nedzelski JM, Chen JM, Lin VY. Results with cochlear implantation in adults with speech recognition scores exceeding current criteria. Otol Neurotol. 2012 Jan;33(1):6-12. doi: 10.1097/MAO.0b013e318239e5a1. — View Citation

Bassim MK, Buss E, Clark MS, Kolln KA, Pillsbury CH, Pillsbury HC 3rd, Buchman CA. MED-EL Combi40+ cochlear implantation in adults. Laryngoscope. 2005 Sep;115(9):1568-73. doi: 10.1097/01.mlg.0000171023.72680.95. — View Citation

Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005. — View Citation

Cullen RD, Higgins C, Buss E, Clark M, Pillsbury HC 3rd, Buchman CA. Cochlear implantation in patients with substantial residual hearing. Laryngoscope. 2004 Dec;114(12):2218-23. doi: 10.1097/01.mlg.0000149462.88327.7f. — View Citation

Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29. — View Citation

Gantz BJ, Turner C, Gfeller KE. Acoustic plus electric speech processing: preliminary results of a multicenter clinical trial of the Iowa/Nucleus Hybrid implant. Audiol Neurootol. 2006;11 Suppl 1:63-8. doi: 10.1159/000095616. Epub 2006 Oct 6. — View Citation

Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014. — View Citation

Gifford RH, Dorman MF, McKarns SA, Spahr AJ. Combined electric and contralateral acoustic hearing: word and sentence recognition with bimodal hearing. J Speech Lang Hear Res. 2007 Aug;50(4):835-43. doi: 10.1044/1092-4388(2007/058). — View Citation

Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831. — View Citation

Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. — View Citation

Gifford RH, Shallop JK, Peterson AM. Speech recognition materials and ceiling effects: considerations for cochlear implant programs. Audiol Neurootol. 2008;13(3):193-205. doi: 10.1159/000113510. Epub 2008 Jan 22. — View Citation

Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am. 1994 Feb;95(2):1085-99. doi: 10.1121/1.408469. — View Citation

PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available. — View Citation

Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059. — View Citation

Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549. — View Citation

Verschuur C, Hellier W, Teo C. An evaluation of hearing preservation outcomes in routine cochlear implant care: Implications for candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:62-5. doi: 10.1080/14670100.2016.1152007. — View Citation

Vickers D, De Raeve L, Graham J. International survey of cochlear implant candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:36-41. doi: 10.1080/14670100.2016.1155809. — View Citation

von Ilberg CA, Baumann U, Kiefer J, Tillein J, Adunka OF. Electric-acoustic stimulation of the auditory system: a review of the first decade. Audiol Neurootol. 2011;16 Suppl 2:1-30. doi: 10.1159/000327765. Epub 2011 May 24. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent correct words recognition in quiet in implanted ear	CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline through 6 months and reported as percentage points improved.	Up to twelve (12 months) post-activation
Primary	Percent correct of words identified for sentences in noise in implanted ear	AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline through 6 months and reported as percentage points improved.	Up to twelve (12 months) post-activation
Secondary	Patient reported improvement in everyday listening conditions	APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) and SSQ (Spatial and Qualities of Hearing) questionnaires will be used to assess subjective outcomes and reported as improvements from baseline to 6 months post-activation.	Up to twelve (12 months) post -activation
Secondary	Number and proportion of subjects experiencing device related adverse events	Adverse events will be collected and reported throughout the duration of the study.	Up to twelve (12 months) post-activation
Secondary	Residual low frequency hearing	HEARRING scale will be used to calculate the percent of hearing preservation for each subject. This data will be summarized through 6 months post-activation.	Up to twelve (12) months post-activation