Table 10:
Summary of Results of Systematic Reviews on Active Transcutaneous Middle Ear Implants vs. No Treatment for Conductive or Mixed Hearing Loss in Adults and Children
| Author, Year | No. of Studies | Results | Quality Assessment |
|---|---|---|---|
| Audiometry | |||
| University of Alberta, 201147 | 32 |
Vibrant Soundbridge vs. no treatment Average functional gains: 27 dBa |
Low quality |
| 10 |
Carina vs. no treatment Average functional gains: 21 dBa |
||
| Australia Medical Services Advisory Committee, 201034 | 4 |
Middle ear implant vs. no treatment in mild–moderate mixed hearing loss Functional gains ranged 26–32 dBa |
Low quality |
| 2 |
Middle ear implant vs. no treatment in severe mixed hearing loss Functional gains ranged 35–49 dBa |
||
| 2 |
Middle ear implant vs. no treatment in conductive hearing loss Functional gains ranged 36–46 dBa |
||
| Ernst et al, 201651 | 6 |
Vibrant Soundbridge vs. no treatment Average functional gains: 30 dBa |
Low quality (nonrandomized intervention studies and observational studies) to high quality (systematic reviews) |
| Klein et al, 201253 | 10 |
Carina vs. no treatment Average functional gains: 21 dBa |
Limited methodological quality |
| Verhaert et al, 201355 | 14 |
Vibrant Soundbridge vs. no treatment Average functional gains: 11–58 dBa |
Low–moderate quality |
| Speech audiometry | |||
| University of Alberta, 201147 | 12 |
Vibrant Soundbridge vs. no treatment Range of speech reception thresholds in quiet: 40–61 dB vs. 58–94 dB (P < .05) |
Low quality |
| 16 | Range of speech recognition: 55%–95% vs. 0%–72% (P < .05) | ||
| 4 |
Carina vs. no treatment Average speech reception threshold gain: 20 dB |
||
| 4 | Range of speech recognition: 69%–94% vs. 33%–40% (P < .05) | ||
| Australia Medical Services Advisory Committee, 201034 | 2 |
Middle ear implant vs. no treatment in mild–moderate mixed hearing loss Improvement in speech perception at conversational levela (numeric data not shown) |
Low quality |
| 1 | Improvement in speech reception thresholdc (numeric data not shown) | ||
| Australia Medical Services Advisory Committee, 201034 (continued) | 1 |
Middle ear implant vs. no treatment in severe mixed hearing loss Improvement in speech perception at conversational level by 48%a |
Low quality |
| 2 | Significant improvement in speech reception threshold in quiet (numeric data not shown) | ||
| 2 |
Middle ear implant vs. no treatment in conductive hearing loss Speech perception in quiet improved by 70%–76% |
||
| 1 | Speech reception threshold improved by 32 dB | ||
| Ernst et al, 201651 | 2 |
Vibrant Soundbridge vs. no treatment Significant improvement in speech perception in noise (SNR 3 dB SPL vs. 12 dB SPLb) |
Low quality (nonrandomized intervention studies and observational studies) to high quality (systematic reviews) |
| Klein et al, 201253 | 10 |
Carina vs. no treatment Speech reception threshold gain: 20 dB |
Limited methodological quality |
| 10 | Word recognition: 69%–94% vs. 33%–40% | ||
| Verhaert et al, 201355 | 13 |
Vibrant Soundbridge vs. no treatment Significant improvement in speech perception in quiet (numeric data not shown) |
Low–moderate quality |
| 4 | Significant improvement in speech perception in noise (numeric data not shown) | ||
| Hearing-specific quality of life | |||
| University of Alberta, 201147 | 5 |
Vibrant Soundbridge vs. no treatment Significant benefits reported in GBI and APHAB (numeric data not shown) |
Low quality |
| 3 |
Carina vs. no treatment Hearing benefits reported in APHAB (numeric data not shown)c |
||
| Australia Medical Services Advisory Committee, 201034 | 1 |
Middle ear implants vs. no treatment in mild or moderate mixed hearing loss Significant benefits reported in APHAB (numeric data not shown) |
Low quality |
| Ernst et al, 201651 | 4 |
Soundbridge vs. no treatment Significant benefit of hearing reported in APHAB device satisfaction reported in HDSS and improvement in general health status reported in GBI (numeric data not shown) |
Low quality (nonrandomized intervention studies and observational studies) to high quality (systematic reviews) |
| Klein et al, 201253 | 3 |
Carina vs. no treatment Significant hearing benefits reported in APHAB (numeric data not shown) |
Limited methodological quality |
| Verhaert et al, 201355 | 4 |
Vibrant Soundbridge vs. no treatment Significant subjective benefits of hearing reported in APHAB (numeric data not shown) |
Low–moderate quality |
| 4 | Improvement in quality of life reported in GBI (numeric data not shown)c | ||
Abbreviations: APHAB, Abbreviated Profile of Hearing Aid Benefit; GBI, Glasgow Benefit Inventory; HDSS, Hearing Device Satisfaction Scale; SNR, signal-to-noise ratio; SPL, sound pressure level.
a
An improvement of 10–15 dB in hearing thresholds is considered clinically important.
b
The lower the SPL, the better the hearing.
c
Statistical significance not reported.