Here's a July 24, 2000 report on the SMPX system FDA panel review I just grabbed off Lexis-Nexis. The highlighted parts are interesting (from an anti-exhuberant POV), but I included the whole article so you will get a complete picture:
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Copyright © 2000 F-D-C Reports, Inc.
M-D-D-I Reports.
The Gray Sheet
Vol. 26; No. 30; Pg. 5
July 24, 2000
TITLE: SYMPHONIX VIBRANT SOUNDBRIDGE CLAIMS SHOULD REFLECT DATA SUBJECTIVITY
Labeling claims should reflect the subjective nature of data obtained from clinical studies supporting FDA approval of Symphonix Devices' Vibrant P and Vibrant D "Soundbridge" implant hearing system, FDA's Ear, Nose and Throat Devices Panel concluded at a July 20 meeting in Gaithersburg, Maryland.
Although the panel voted unanimously (7-0) to recommend that FDA approve the firm's premarket approval application, the recommendation was saddled with 11 conditions, the majority of which focused on proposed claims pertaining to device efficacy.
Panel member Ross Roeser, PhD, University of Texas, Dallas said he was "uncomfortable making comparisons" using study results because the data is "based on a subjective questionnaire."
"We are being asked to base [our] opinion on a test developed by the manufacturer to test the manufacturers device, he explained, noting, "On the surface [that] seems inappropriate."
Agency reviewer Teri Cygnarowicz also noted that "FDA is concerned [that] much of the effectiveness data are based on subjective questionnaire."
Incorporating Floating Mass Transducer technology, the Vibrant Soundbridge devices mimic and amplify the movements of the ossicles by converting electrical signals into mechanical vibrations. In addition to the FMT, the system consists of the VORP implanted receiver and one of two versions of an audio processor.
Submitted in the third quarter of 1999, the final shell of the modular premarket approval covered both the Vibrant P programmable analog version of the audio processor and the Vibrant D, which offers digital signal processing. Virtually no distinction was made between the two versions of the device during panel review.
As one of the conditions for approval, the panel recommended that the intended use for the products be modified to reflect that they are approvable for treatment of moderate-to-severe sensorineural hearing loss, provided patients have prior experience with appropriately fitting hearing aids.
The panel agreed that the device should be indicated for use in adults 18 years of age or older who have a moderate-to-severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid.
For the purpose of the study, the firm elected to compare the system to "appropriately fit" hearing aids. The Vibrant device differs in that it is implanted into the ear and requires a surgical procedure similar to that used during stapedection procedures (stapes prosthesis) and cochlear implant surgery.
While all three surgical approaches are relatively similar, each implant yields a different outcome once the implant is in place, making comparisons between these types of devices irrelevant, the firm explained.
"Because no bones are removed, a patient's hearing remains the same before and after the [Soundbridge] operation without the device turned on," explained Symphonix investigator Thomas Balkany, MD, University of Miami.
Data derived from baseline audiometric tests of patients wearing hearing aids were compared with data from the same patients after implantation of the Soundbridge. Investigators evaluated pure-tone air-and-bone conduction, tympanometry and acoustic reflexes, aided and unaided word recognition and soundfield thresholds, hearing aid electro-acoustic analysis and real ear measures. In addition, three patient self-assessment questionnaires were used.
Results from the Phase III trial, conducted at 10 U.S. sites, demonstrated a significant improvement in hearing level compared to conventional acoustic hearing aids and in degree of patient satisfaction.
Data derived from 54 individuals showed that 86% of Soundbridge implant patients expressed satisfaction in improved sound quality and clarity versus 31% satisfaction of those fitted with a hearing aid.
Major adverse events reported in the U.S. included two patients with clinically significant change in residual hearing, device failure in six patients, and disconnection of the FMT from the incus in one patient. Three minor adverse events also were reported.
The panel conditioned its recommendation on the company agreeing to follow in its post-market study the incidence of device extrusion.
Labeling changes were also recommended as a condition for approval. Specifically, panel members noted that language should be added to reflect the possibility that facial nerve paralysis and taste disturbance could occur following implantation.
In addition, because individuals enrolled in the trial were implanted only in one ear with the Soundbridge while the other ear was fitted with a hearing aid, a cautionary statement in labeling should indicate that data has not yet been generated on patients for use in both ears, panel members suggested.
Company officials indicated, however, that its near-term plans do not include marketing of the device for use with both ears.
"Symphonix supports the use of amplification along with the implant system," noted Deborah Arthur, company VP-Clinical Affairs.
FDA reviewers also raised concern over the fact that the devices are incompatible with magnetic resonance imaging procedures.
"The MRI is being used in more and more procedures and diagnostics, so the fact that [the Soundbridge] is not compatible is an issue for me," FDA Clinical Reviewer/Medical Officer Sidney Jaffee opined.
However, the company noted that widespread testing to prove that MRI procedures are incompatible with the system have not yet been conducted. In addition, labeling would include cautionary language pertaining to MRI incompatibility, the company noted.
While the firm presented data supporting ten efficacy claims, panel members recommended that seven of those statements be changed to ensure that patients understand the subjective nature of the data.
For example, one claim originally proposed by the firm stated the device "does not significantly affect residual hearing." However, panel members recommended that the statement also include at the beginning of the sentence "for most subjects," to make the claim seem less evidence-based.
Overall, panel members were enthusiastic about the device. "It is an exciting new technology," Roeser said. "We can look at the future and hope patients who need this type of technology will benefit from it."
On July 19, San Jose, California-based Symphonix reported net loss in the second quarter (ended June 30) of $4.1 mil. on sales of $200,000 compared to a $8.4 mil. net loss on sales on $413,000 in the same quarter one year ago. |
