During a recent U.S. Clinical trial held in multiple locations throughout the U.S., the Esteem^® prosthetic hearing restoration device showed marked improvement for a majority of recipients implanted. Below are definitions of the tests conducted with corresponding results.

All implanted recipients in this trial were current hearing aid users. The average time of hearing aid use was over 13 years. Of the subjects implanted, 86% used hearing aids in both ears.

Description of Tests Used to Evaluate Esteem®

Speech Reception Threshold (SRT)

These tests try to determine the faintest level at which a person can hear and correctly repeat two-syllable (spondaic) words. When the individual hears a word, he or she repeats the word (or points to pictures) as the audiologist´s voice gets softer and softer. The faintest level, in decibels, at which 50% of the two-syllable words are correctly identified, is recorded as the Speech Reception Threshold (SRT). A separate SRT is determined for each ear.

Word Recognition (WRS)

These tests attempt to evaluate how well a person can distinguish words at a comfortable loudness level. It relates to how clearly one can hear single-syllable (monosyllabic) words when speech is comfortably loud. In this test, the audiologist´s voice (or a recording) stays at the same loudness level throughout. The individual being tested repeats words (or points to pictures). The percentage of words correctly repeated is recorded for each ear. Thus, a score of 100% would indicate that every word was repeated correctly. A score of 0% would suggest no understanding. Word recognition is typically measured in quiet.

The APHAB (Abbreviated Profile of Hearing Aid Benefit)

This test is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication or noises in various everyday situations. Benefit is calculated by comparing the patient´s reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 categories: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness to Loud Sounds (AV).

Quality of Life (QOL) Measurement

After ten months of using the Esteem®, patients were asked to complete a questionnaire subjectively rating their experience with their Esteem® as compared to their experiences with their pre-implant hearing aid (aided condition).

Results of Tests

Results of Speech Reception Threshold (SRT)

Overall, the mean SRT improvement with the Esteem® compared to the pre-implant hearing aid was 10.6 dB with the range of mean improvement between 1.3-16.9 dB. SRT Improvement varied due to clinical site variability.

Results of Word Recognition (WRS)

Overall, 93% of Esteem® recipients scored equal to or better than their pre-implant hearing aid.

• 7% Scored less than their pre-implant hearing aid (0%-20% depending upon clinical site)
• 37% Scored equal to their pre-implant hearing aid ( 17%-53% depending upon clinical site)
• 56% Scored better than their pre-implant hearing aid (27%-83% depending upon clinical site)

Results of APHAB (Abbreviated Profile of Hearing Aid Benefit)

Overall, 80% of Esteem® recipients rated Esteem® better than or equal to their pre-implant hearing aid in the APHAB questionnaire.

• 19% Rated Esteem® below the hearing aid 
  • (7%-33%, depending upon clinical site)
• 21% Rated Esteem® equal to the hearing aid 
  • (11%-29%, depending upon clinical site)
• 60% Rated Esteem® better than the hearing aid (56%-64%, depending upon clinical site)

Results of Quality of Life (QOL) Measurement

The results of the questionnaire indicate that a strong majority of patients consider the Esteem® somewhat or much better than their hearing aid.

Activity Level:

• 85% somewhat-much better;
• 11% equal
• 4% somewhat-much worse

Feeling of Confidence:

• 84% somewhat-much better
• 8% equal
• 8% somewhat-much worse

Clarity of Sound:

• 78% somewhat-much better
• 7% equal
• 15% somewhat-much worse

Natural Sounding Voices:

• 76% somewhat-much better
• 11% equal
• 13% somewhat-much worse

Understanding Conversation:

• 72% somewhat-much better
• 17% equal
• 11% somewhat-much worse

Ability to Understand Speech in Noise:

• 69% somewhat-much better
• 13% equal
• 18% somewhat-much worse

Benefit of Invisibility:

• 66% somewhat-much better
• 17% equal
• 17% somewhat-much worse

Individual results may vary