**Warning:**	The NCBI web site requires JavaScript to function. 	more...

An official website of the United States government

**The .gov means it's official.**							Federal government websites often end in .gov or .mil. Before							sharing sensitive information, make sure you're on a federal							government site.						

**The site is secure.**							The **https://** ensures that you are connecting to the							official website and that any information you provide is encrypted							and transmitted securely.						

Log in

#### Account

                          - Dashboard
                          - Publications
                          - Account settings
                          - Log out

Access keysNCBI HomepageMyNCBI HomepageMain ContentMain Navigation

# Bookshelf

## 

                -  Browse Titles 
                -  Advanced 
                -  Help 
                -  Disclaimer 

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

AHCPR Health Technology Reviews. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1995. 

                        - This publication is provided for historical reference only and the information may be out of date.

**This publication is provided for historical reference only and the information may be out of date.**

## AHCPR Health Technology Reviews.

Show details

Agency for Health Care Policy and Research (US)

                            - Contents

< PrevNext >

#  3Cochlear Implantation in Outpatient Settings

Martin Erlichman, MS and Thomas V Holohan, MD.

Published: 1992.

## Report

This review examines the appropriateness of performing cochlear implant procedures in                outpatient clinical settings including ambulatory surgical centers. A cochlear                implant is a prosthetic device used to produce the sensation of sound through the                generation of electrical signals, which are perceived as an analog of environmental                sound waves.(1). Most patients with                profound sensorineural deafness (no useful hearing) have lost the hair cells that                transduce acoustic vibrations into electrical activity in the auditory nerve. Of the                15 million persons in the United States with significant hearing impairment, fewer                than 1 are considered potential candidates for a cochlear implant.(2). Cochlear implant systems employ an                externally worn microphone, signal (speech) processor, and transmitter to receive                sound and produce electrical signals. (3).                The prosthesis includes a surgically implanted receiver and electrode to excite the                remaining auditory nerve fibers electrically according to a speech-processing                algorithm that is driven by the signals picked up by the external microphone, thus                inducing sensations of sound in the patient.

A multichannel device with as many as 22 electrodes (electrode arrays), each of which                can be stimulated independently, has been developed. Two multichannel devices are                approved for marketing by the Food and Drug Administration: the 3M Company device                (for adults only) and the Nucleus device from Cochlear Corporation (for children and                adults). Only the Nucleus device is currently being implanted. 

Approximately 300 to 500 cochlear implant procedures are performed each year in the                United States. A small but growing number are being performed as outpatient                procedures, and Medicare has recently added cochlear implantation to its list of                covered surgical services provided at ambulatory surgical centers. There is no                evidence that any cochlear implant operation has been performed in an ambulatory                surgical center.

The implantation procedure, considered delicate but not complex or risky, enables the                surgeon to fasten an electrode array in the vicinity of auditory nerve fibers while                maintaining the integrity of both the inner and middle ears. The operation is                performed under strictly aseptic conditions, and a general anesthetic is used. The                surgical procedure includes the creation of a large scalp flap; a mastoidectomy is                then performed utilizing an approach through the facial recess to the middle ear                that exposes the round window of the cochlear base. A seat (bed) is formed in the                mastoid, parietal, and/or occipital bones to retain the signal-receiving and                stimulation device, which is from 1.5 to 2.5 cm in diameter and about 0.5 cm thick.                The electrode array is inserted into the scala tympani via the round window, and the                receiving coil is fastened in its surgically formed recess. This procedure usually                takes from 1.5 to 3 hours.(1,3). The surgical implant operation for                children is similar but requires modifications of the surgical technique.(4). A transorbital radiograph of the                patient, to document and ensure electrode position, is taken immediately after the                surgery. In most cases patients are hospitalized (observed) for 24 to 48 hours after                surgery.

Possible medical complications include all those associated with general anesthesia.                Published data regarding inhospital cochlear implantation indicate few postoperative                    complications.(1,5). Major complications are usually related to surgical                technique, and they include flap necrosis, improper electrode placement, and rare                facial nerve problems. Minor complications include dehiscence, infection, facial                nerve stimulation, and dizziness.(5).

According to Kveton and Balkany,(1).                clinical trials with two cochlear implant devices in almost 500 children produced                significant complications in 2.4 in the 3M series and 3.5 in the Nucleus series.                Complications included infection and extrusion, pain and inflammation, delayed wound                healing and extrusion, skin flap complications, transient drainage, electrode                displacement or misplacement, and facial nerve damage. Complications were                successfully resolved, except in one patient with an unresolved but improved facial                palsy.

The recent review by Cohen and Hoffman(5).                of the surgical experience of 696 adults and 309 children in the United States found                that there have been no deaths attributable to implantation of these devices, few                serious major complications, and relatively few minor complications. (Major                medical-surgical complications are those that require additional surgery and/or                hospitalization, and minor complications are those that are treated with medication                alone.) Complications were less frequent in children than in adults but were more                likely to occur in younger children than in those older than 7 years of age.

A review of 459 implants with the Nucleus device in adults(5). found 23 (5) major complications and 32 (7) minor                complications. Major complications included scalp breakdown requiring implant                removal; compressed or incorrect electrode position; perilymph fistula; severe                seventh nerve stimulation leading to implant removal; and one life-threatening case                of meningitis, which resolved under treatment. Minor complications included flap                problems; seventh nerve weakness or stimulation; and transient dizziness.

There are no published data that specifically address the operative morbidity or                clinical effectiveness of cochlear implantation in outpatient settings. Opinions                from acknowledged leaders in the field or cochlear implantation were sought in lieu                of the data needed to compare the safety and clinical effectiveness of inpatient and                outpatient procedures.

According to Maureen Hannley, Director of Research, American Academy of                Otolaryngology-Head and Neck Surgery, cochlear implantations can be performed safely                and effectively in outpatient settings, including ambulatory surgical centers. The                procedure is considered not especially difficult nor more complicated than other                procedures presently performed by otolaryngologists in outpatient settings.                Professional judgment on the part of the clinician should determine which patients                are not suitable for outpatient surgery. Some patients may require an impatient                procedure because of coexisting morbidity (e.g., diabetes or epilepsy).

Some of the leading otolaryngologists performing cochlear implantation in the United                States believe that the safety of the patient as well as the clinical effectiveness                of the procedure are not diminished by implantation in an outpatient setting when                protocols and guidelines are established to maintain safe and effective surgical                outcomes (personal communications, Juliana Gulya, Georgetown University; Thomas                Balkany, University of Miami; Noel Cohen, New York University; and Richard Miyamota,                University of Indiana).

Adequate training in cochlear implantation, regardless of the setting, is essential.                An overnight stay is considered a minimal requirement for appropriate care and                observation and to allow for recovery from anesthesia and any dizziness that may                occur, the detection of infection, and the removal of drains. A Public Health                Service official at the National Institutes of Health, who is recognized as a                national expert in the field of deafness, was consulted. In his opinion, cochlear                implantation can be performed safely and effectively in an outpatient setting and                should include an overnight stay to provide proper patient management and                observation.

In regard to outpatient cochlear implantation, there is no evidence, based on the                information obtained by this Office, that the safety of the patient and                effectiveness of the procedure would be compromised as long as the same protocols                and guidelines utilized for inpatient procedures are practiced. Such practices would                also include allowing the patient to remain in a medical facility overnight for                postoperative observation and treatment deemed clinically necessary, as well as                providing for additional observation time or hospitalization as required. 

##  References

                        - 1.
                        - Kveton J, Balkany TH. Status of cochlear implantation in children.  J Pediatr.  1991;118:1–7. [PubMed: 1986072]
                        - 2.
                        - Concensus Development Panel. National Institutes of Health Consensus Development Conference                        Statement on Cochlear Implants.  Arch Otolaryngol Head Neck Surg.  1989;115:31–36. [PubMed: 2642379]
                        - 3.
                        - [no authors listed] Cochlear Implant Devices for the Profoundly                        Hearing Impaired  Health Technology Assessment                        Report  1986No. 2, Rockville, MD:                    National Center for Health Services Research and Health Care Technology                    Assessment. 
                        - 4.
                        - Clark GM, Cohen NL, Shepherd RK. Surgical and safety considerations of multichannel cochlear                        implants in children.  Ear Hear.  1991;12(4):15S–24S. [PubMed: 1955086]
                        - 5.
                        - Cohen NL, Hoffman RA. Complications of cochlear implant surgery in adults and                        children.  Ann Otol Rhinol Laryngol.  1991;100:708–711. [PubMed: 1952660]

                        - 
AHCPR Pub. No. 92-0072

Copyright Notice

Bookshelf ID: NBK63970

Contents
< PrevNext >

Share

### Views

                    - PubReader
                    - Print View
                    - Cite this Page Erlichman M, Holohan TV. Cochlear Implantation in Outpatient Settings. 1992. In: AHCPR Health Technology Reviews. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1995.  3.

### In this Page

                    - Report
                    -  References

### Other titles in this collection

                    - Health Services/Technology Assessment Text (HSTAT)

### Recent Activity

ClearTurn OffTurn On
                      - Cochlear Implantation in Outpatient Settings - AHCPR Health Technology Reviews Cochlear Implantation in Outpatient Settings - AHCPR Health Technology Reviews 
                      - Pressure Ulcers in Adults: Prediction and Prevention Pressure Ulcers in Adults: Prediction and Prevention 
                      - Treatment of Pressure Ulcers Treatment of Pressure Ulcers 
                      - Citing Medicine Citing Medicine 
                      - Effectiveness of Assisted Reproductive Technology Effectiveness of Assisted Reproductive Technology 

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on
See more...

TwitterFacebookLinkedInGitHubNCBI Insights Blog

Connect with NLM
                      - Twitter
                      - Facebook
                      - Youtube

National Library of Medicine8600 Rockville Pike							Bethesda, MD 20894

Web PoliciesFOIAHHS Vulnerability Disclosure

HelpAccessibilityCareers

-  NLM 
-  NIH 
-  HHS 
-  USA.gov