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Assessing Safety and Effectiveness of

Cochlear Implants in Sweden

G. Bredberg, F. Albert and G. Liedström

Published in Christman & Albert: Cochlear Implants: A Model for the Regulation Emerging Medical Device Technologies.  MTT Press 1993. New York.

 

The cochlear implant program in Sweden

  ln 1980, at the urging of profoundly deaf persons, medical audiologists and otolaryngologists, the Swedish Institute for the Handicapped initiated a study of the status of cochlear implants in Sweden. The purpose was to study the different typos of implant, evaluate the reported results, and plan a strategy for the Swedish cochlear implant program. A study group was established, consisting of specialists in ENT, audiology and speech research. The literature was surveyed and implant teams in Vienna, Paris and London were visited. Members of the study team also attended several international conferences on cochlear implants and professors Burian and E, Hochmair were invited to present papers on their work.

In 1983, the Swedish Medical Research Council sponsored a 'state of the art' conference on cochlear implants. Representatives from all major implant study groups attended As a result of the papers and discussion, attendees reached agreement that cochlear implants could be considered an established rehabilitation method for the profoundly deaf adult, However, there was no agreement regarding ding safety and effectiveness of the operation for children.

As a result of the conference, a 3 year pilot project was begun at the Department of Audiology and Otolaryngology at Sodersjukhuset Hospital in Stockholm, in cooperation with the Department of Speech Communication arid Music Acoustics at the Royal Institute of Technology. Assisting in the study were individuals from the Handicap Institute, patient organizations and the Karolinska Institute. Ten patients were to receive the Vienna/3M extracochlear implant, then be evaluated as a basis for further decisions. The study group chose this implant, which does not require surgical access to the labyrinth, because they were not convinced that better results would be obtained with intracochlear systems. Also, this choice left open the possibility of later reimplantation with an intracochlear electrode if it were proven that such systems gave better results and were not harmful to the inner ear and auditory nerve.

 

Preoperative testing

A preoperative evaluation was made to ensure that each prospective implant patient had been adequately fitted with a hearing aid, had been trained to use any remaining residual hearing :and received auditory sensations from electrical stimulation. The quality of these sensations was also assessed.

After complete otological evaluation, researchers used audiometry and hearing aid testing to determine the extent of any remaining hearing. Further testing involved the Swedish version of the MAC test battery, a speech test using the Risberg and Agelfors (1983) method, vestibular testing, a CT scan, and electrical promontory stimulation.

Each patient underwent a psychological test battery including the Defense Mechanism Test, Ravcn's matrices and Q‑sorting. A clinical interview helped in establishing a psychological profile for each patient and setting realistic expectations (see below). Finally, patients were required to perform tests with a vibro‑tactile device, after a short training period. Each patient's voice was recorded to enable postoperative evaluation of changes due to auditory feedback from the implant.

All patients who participated in the study met the following criteria: postlingual deafness, 20-70 years old, no help (or very limited help) with a hearing aid or vibro-tactile device in the specific speech tests, realistic expectations, and good motivation.  

 

Postoperative procedure and rehabilitation  

As a part of the postoperative fitting procedures, patients were first familiarized with the new sounds, then the speech processor was adjusted to obtain comfortable and equal loudness over the entire frequency range. During this process, the output signal was limited to prevent patient discomfort.

In addition to home training after the initial fitting, patients trained at the Department three times a week for 2 months then twice a week for 6 months. As the program at the Department progressed a computer‑aided system that includes most of the MAC test battery was used increasingly. A home audiotape program with sounds, syllables, words and sentences was also developed.

   

Psychological Aspects 

An individual's loss of hearing can alter his self‑image and his interpersonal relationships, as well as his communication pattern. A cochlear implant may reverse a hearing loss, and yet be psychologically upsetting. Some patients who meet the medical criteria for a cochlear implant have psychopathologies, including defective defense mechanisms, that can lead to unexpected complications. Thus, each patient's psychological status and adaptive capacity must be assessed and patients should be prepared for their new circumstances. These considerations are crucial to our continuing efforts to optimize the post‑operative rehabilitation program.

Implant candidates must be screened to rule out acute psychological crises. The prospect of recovered hearing generally produces only positive expectations; patients do not anticipate any new challenges or negative consequences. In fact, candidates often expect all aspects of life to improve after implantation. Hence, it is important to determine whether hearing improvement is likely to make a positive contribution to mental health or whether unrealistic expectations may ultimately produce negative results.

An adequate general intellectual capacity, especially in the areas of inductive reasoning and verbal skills, is needed for implant candidates. Successful adaptation to an implant requires the ability to correctly interpret new stimuli.

A degree of psychological stability is also needed. Patients who have extreme psychological reactions to deafness or to the frustrations of everyday life arc not good implant candidates. To investigate patients' defense mechanisms and personal adjustment, clinical interviews should be combined with standardized testing of personality characteristics.

Patient motivation and expectations, both conscious and unconscious, must be investigated carefully. Patient understanding of the advantages arid limitations of the implant creates the best chance for successful adjustment after the operation. Thus, the entire Swedish cochlear implant team, including the psychologist, helps to inform patients about various aspects of the implant.

Patients are not the only ones who need to understand the possibilities and limits of a cochlear implant. Implant patients, like hearing aid users, are sometimes expected to communicate in situations that demand more than their limited abilities, notably via telephone. Even the implant team sometimes expects lo much, creating a burden on the patients. The success of an implant should be judged by more than just the number of words and syllables the patient can recognize; contributions to the quality of life should also be included.

   

Results 

Communication Skills  

Implant recipients in the pilot project have achieved the following: They have demonstrated an increase in their ability to detect the presence of sound and recognize many everyday sounds. They have developed very good support for their lipreading; on average they have almost doubled their communication skills. They can hear their own voices and thereby modulate their speech better. Half of them can recognize some words without lip-reading and one of the 10 can hold a simple telephone conversation.

During the post-implant training program, the improvement has been striking for all patients, especially after 6 months. Further improvement continues 3 years after implantation.

 

Psychological results 

A major change frequently reported by implant recipients is the feeling of being part of the world again as a result of hearing the variety of sounds in normal life. Improved hearing also provides an improved sense of personal safety. For example, potential dangers can be detected when walking outside and the presence of others can be detected even when one is engrossed in some task. The improved sense of safety in return reduces anxiety, several patients have reported increases in working capacity and general vitality,

For some patients, a cochlear implant can decrease dependency, increase confidence, and enable more satisfying patterns in social relations.

   

Complications 

Of the 10 patients, two had a minor postoperative skin flap infection. Another patient had small seborrheic wounds in the scalp; one year after surgery he reported to the hospital with a wound penetrating to the depth of the receiver and a staphylococcus infection. The receiver and electrodes were surrounded by pus and granular tissue down to the middle ear, which was itself completely free of infection. The lesion healed after removal of the implant and treatment with cloxacillin. The patient was later reimplanted without any complications.

Two of the early patients suffered a sliding of the extracochlear electrode because of insufficient support in the mastoid loop. In later patients this was not a problem because the technique was changed to direct the course of the electrode so that it would be supported by bone in the mastoid tip, thus preventing retraction. The first six patients had a receiver enclosed in epoxy; after three years four of them experienced a deterioration in hearing threshold and the other two had a functional failure of the implant. The receivers encased in ceramic material, used for the remaining four patients, have not deteriorated in the 1.5‑4 years since implantation; in fact, performance has continuously improved.

Three of the patients with the epoxy enclosure were reimplanted with a Vienna/3M single‑channel intracochlear device, resulting in lower hearing thresholds and increased dynamic range. The fourth patient was reimplanted with an intracochlear 22‑channel Cochlear Corporation device.

 

Eight out of the ten patients showed no vestibular function when tested with caloric and rotatoric stimulation before surgery. None of these had any vestibular symptoms after surgery or at stimulation. Of the two patients with intact vestibular function, one initially had vertigo after surgery and during sound stimulation.

Two patients had preoperative periods of severe tinnitus; this condition was not influenced by implantation. Four of the five patients who had moderate or slight tinnitus showed some relief after implantation.

Future implantation strategy  

That the introduction of a new surgical technique like cochlear implantation presents risks is apparent. On the other hand the risk of harm to the patient or deterioration of the remaining neural function of the cochlea seems small even if an intracochlear electrode is used. No threatening infections have occurred. However, the effect of replacing electrodes is not clear. Animal experimentation has shown that the trauma of inserting the original electrode is small, but the risk of damage from electrode replacement is greater. Hence, it is very important to use an electrode that will minimize trauma.

It is interesting that clinical experience does not show any decrease in performance after replacing electrodes. For the sake of resolving remaining questions, it is desirable that all future studies be done in a controlled fashion with careful follow up to ensure reporting of any disturbances or complications. Standardized hearing tests should be developed to enable comparison of results between different implantation teams.

 

 

 

 

   

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